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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00391872




Registration number
NCT00391872
Ethics application status
Date submitted
23/10/2006
Date registered
25/10/2006
Date last updated
13/03/2012

Titles & IDs
Public title
A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome
Scientific title
A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]
Secondary ID [1] 0 0
PLATO
Secondary ID [2] 0 0
D5130C05262
Universal Trial Number (UTN)
Trial acronym
PLATO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor
Treatment: Drugs - Clopidogrel

Active Comparator: Clopidogrel - Oral treatment

Experimental: Ticagrelor - Oral treatment


Treatment: Drugs: Ticagrelor
Ticagrelor (AZD6140) 90 mg twice daily dose (BD)

Treatment: Drugs: Clopidogrel
Clopidogrel 75 mg once daily dose (ODD)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke - Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.
Timepoint [1] 0 0
Randomization up to 12 months
Primary outcome [2] 0 0
Participants With Any Major Bleeding Event - Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
Timepoint [2] 0 0
First dosing up to 12 months
Secondary outcome [1] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization - Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.
Timepoint [1] 0 0
Randomization up to 12 months
Secondary outcome [2] 0 0
Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke - Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee.
Timepoint [2] 0 0
Randomization up to 12 months
Secondary outcome [3] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events. - Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated.
Timepoint [3] 0 0
Randomization up to 12 months
Secondary outcome [4] 0 0
Participants With MI Event - Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
Timepoint [4] 0 0
Randomization up to 12 months
Secondary outcome [5] 0 0
Participants With Death From Vascular Causes - Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
Timepoint [5] 0 0
Randomization up to 12 months
Secondary outcome [6] 0 0
Participants With Stroke - Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
Timepoint [6] 0 0
Randomization up to 12 months
Secondary outcome [7] 0 0
Participants With Death From Any Cause - Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.
Timepoint [7] 0 0
Randomization up to 12 months
Secondary outcome [8] 0 0
Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding - Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
Timepoint [8] 0 0
First dosing up to 12 months
Secondary outcome [9] 0 0
Participants With Major or Minor Bleeding - Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
Timepoint [9] 0 0
First dosing up to 12 months
Secondary outcome [10] 0 0
Participants With Non-procedural Major Bleeding - Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
Timepoint [10] 0 0
First dosing up to 12 months
Secondary outcome [11] 0 0
Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding - Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.
Timepoint [11] 0 0
First dosing up to 12 months
Secondary outcome [12] 0 0
Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding - Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.
Timepoint [12] 0 0
First dosing up to 12 months
Secondary outcome [13] 0 0
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization - Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists.
Timepoint [13] 0 0
1-week period following randomization
Secondary outcome [14] 0 0
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization - Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists.
Timepoint [14] 0 0
1-week period following randomization

Eligibility
Key inclusion criteria
- Male or female 18 years or older who has been hospitalised for chest pain and
potential ACS

- Females of child-bearing potential must have a negative pregnancy test at enrollment
and be willing to use 2 methods of reliable contraception
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Persons with moderate or severe liver disease

- Persons who have already been treated with an invasive (angioplasty) procedure for the
current episode of ACS

- Persons who are being treated with blood clotting agents that cannot be stopped

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Bruce
Recruitment hospital [2] 0 0
Research Site - Chermside
Recruitment hospital [3] 0 0
Research Site - Herston
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Research Site - Woolloongabba
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Research Site - Bedford Park
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Research Site - Dandenong
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Research Site - Geelong
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Research Site - Melbourne
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Research Site - Perth
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- Bruce
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- Chermside
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- Herston
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- Woolloongabba
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- Bedford Park
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- Dandenong
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- Geelong
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- Melbourne
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- Perth
Recruitment outside Australia
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Hang Zhou
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Shanghai, Pudong
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CZ
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Teplice
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Usti Nad Labem
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Zlin
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Hjorring
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Kolding
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Odense C
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Roskilde
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Slagelse
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Viborg
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Jyvaskyla
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Lahti
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Lappeenranta
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Pori
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Rovaniemi
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Turku
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Arras
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Avignon
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Besancon
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France
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Brest
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France
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Caen
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France
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Cholet
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France
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Creteil
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France
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Croix
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France
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Dijon
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Douai
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Falaise
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Frejus
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La Rochelle
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France
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France
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Lille
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France
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Limoges
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France
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Lomme
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France
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Marseille
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France
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PAU
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Pessac
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France
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Quincy Sous Senart
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Rennes
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France
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Rouen
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France
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Senlis
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France
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France
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Tourcoing
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France
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Georgia
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
State/province [197] 0 0
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Heidelberg
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Germany
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Jena
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Germany
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Germany
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Germany
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Limburg
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Germany
State/province [218] 0 0
Lubeck
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Germany
State/province [219] 0 0
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Germany
State/province [220] 0 0
Merseburg
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Germany
State/province [221] 0 0
Monchengladbach
Country [222] 0 0
Germany
State/province [222] 0 0
Muhlheim An Der Ruhr
Country [223] 0 0
Germany
State/province [223] 0 0
Munster
Country [224] 0 0
Germany
State/province [224] 0 0
Regensburg
Country [225] 0 0
Germany
State/province [225] 0 0
Rostock
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Germany
State/province [226] 0 0
ULM
Country [227] 0 0
Germany
State/province [227] 0 0
Warendorf
Country [228] 0 0
Germany
State/province [228] 0 0
Witten
Country [229] 0 0
Germany
State/province [229] 0 0
Wuppertal
Country [230] 0 0
Germany
State/province [230] 0 0
Wurzburg
Country [231] 0 0
Greece
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Crete
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Greece
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Athens
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Greece
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Larissa
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Greece
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Patra
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Greece
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Piraeus
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Greece
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Country [237] 0 0
Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
State/province [239] 0 0
Cegled
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Hungary
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Debrecen
Country [241] 0 0
Hungary
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Gyula
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Hungary
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Hodmez-vasarhely
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Hungary
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Kaposvar
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Hungary
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Kecskemet
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Hungary
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Hungary
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Pecs
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Hungary
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Szekesfehervar
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Hungary
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Country [249] 0 0
India
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Andhrapradesh
Country [250] 0 0
India
State/province [250] 0 0
Delhi
Country [251] 0 0
India
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Gujarat
Country [252] 0 0
India
State/province [252] 0 0
Karnataka
Country [253] 0 0
India
State/province [253] 0 0
Kerala
Country [254] 0 0
India
State/province [254] 0 0
Madhya Pradesh
Country [255] 0 0
India
State/province [255] 0 0
Maharashtra
Country [256] 0 0
India
State/province [256] 0 0
Punjab
Country [257] 0 0
India
State/province [257] 0 0
Rajasthan
Country [258] 0 0
India
State/province [258] 0 0
Tamilnadu
Country [259] 0 0
India
State/province [259] 0 0
West Bengal
Country [260] 0 0
Indonesia
State/province [260] 0 0
Bali
Country [261] 0 0
Indonesia
State/province [261] 0 0
Jawa Barat
Country [262] 0 0
Indonesia
State/province [262] 0 0
Jawa Timur
Country [263] 0 0
Indonesia
State/province [263] 0 0
Jakarta
Country [264] 0 0
Indonesia
State/province [264] 0 0
Makassar
Country [265] 0 0
Indonesia
State/province [265] 0 0
Semarang
Country [266] 0 0
Israel
State/province [266] 0 0
Afula
Country [267] 0 0
Israel
State/province [267] 0 0
Ashkelon
Country [268] 0 0
Israel
State/province [268] 0 0
Beer Sheva
Country [269] 0 0
Israel
State/province [269] 0 0
Hadera
Country [270] 0 0
Israel
State/province [270] 0 0
Haifa
Country [271] 0 0
Israel
State/province [271] 0 0
Holon
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Israel
State/province [272] 0 0
Jerusalem
Country [273] 0 0
Israel
State/province [273] 0 0
Poriya M.p. Lower Galilee
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Israel
State/province [274] 0 0
Rehovot
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Israel
State/province [275] 0 0
Tel Aviv
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Israel
State/province [276] 0 0
Zerifin
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Italy
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AN
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Italy
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BA
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Italy
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BG
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Italy
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CE
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Italy
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CT
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Italy
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FE
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Italy
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FG
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Italy
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FI
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Italy
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MI
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MN
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MO
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PE
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Italy
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PV
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Roma
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Italy
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SS
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Italy
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TV
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Italy
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VA
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Italy
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VE
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Italy
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VR
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Italy
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Massa Carrara
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Italy
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Napoli
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Italy
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Novara
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Suwon
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Korea, Republic of
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Sarawak
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Malaysia
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Wilayah Persekutuan
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Distrito Federal
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Mexico
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Mexico
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Mexico
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Durango
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Mexico
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Puebla
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Netherlands
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Netherlands
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Almelo
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Netherlands
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Amersfoort
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Netherlands
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Amsterdam
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Netherlands
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Netherlands
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Arnhem
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Netherlands
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Assen
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Netherlands
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Blaricum
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Netherlands
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Netherlands
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Capelle Aan Den Ijssel
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Netherlands
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Delft
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Netherlands
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EDE
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Helmond
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Netherlands
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Netherlands
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Netherlands
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Maastricht
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Tiel
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Netherlands
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Netherlands
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Veldhoven
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Netherlands
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Arendal
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Norway
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Bergen
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Norway
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Bodo
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Norway
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Drammen
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Norway
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Flekkefjord
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Norway
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Gjovik
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Norway
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Hamar
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Norway
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Kongsberg
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Norway
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Kristiansand
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Norway
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Lillehammer
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Norway
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Nordbyhagen
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Norway
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Oslo
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Norway
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RUD
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Norway
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Tromso
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Norway
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Cebu
Country [367] 0 0
Philippines
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Davao City
Country [368] 0 0
Philippines
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Manila
Country [369] 0 0
Philippines
State/province [369] 0 0
Pasig City
Country [370] 0 0
Philippines
State/province [370] 0 0
Quezon City
Country [371] 0 0
Poland
State/province [371] 0 0
Bialystok
Country [372] 0 0
Poland
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Bielsko-biala
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Poland
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Bydgoszcz
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Poland
State/province [374] 0 0
Bytom
Country [375] 0 0
Poland
State/province [375] 0 0
Czestochowa
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Poland
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Elblag
Country [377] 0 0
Poland
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Gda?sk
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Poland
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Gdynia
Country [379] 0 0
Poland
State/province [379] 0 0
Grodzisk Mazowiecki
Country [380] 0 0
Poland
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Inowroclaw
Country [381] 0 0
Poland
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Katowice
Country [382] 0 0
Poland
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Krakow
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Poland
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Lodz
Country [384] 0 0
Poland
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Lublin
Country [385] 0 0
Poland
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Olawa
Country [386] 0 0
Poland
State/province [386] 0 0
Olsztyn
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Poland
State/province [387] 0 0
Opole
Country [388] 0 0
Poland
State/province [388] 0 0
Ostrowiec Swietokrzyski
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Poland
State/province [389] 0 0
Plock
Country [390] 0 0
Poland
State/province [390] 0 0
Poznan
Country [391] 0 0
Poland
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Radom
Country [392] 0 0
Poland
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Szczecin
Country [393] 0 0
Poland
State/province [393] 0 0
Tarnow
Country [394] 0 0
Poland
State/province [394] 0 0
Torun
Country [395] 0 0
Poland
State/province [395] 0 0
Walbrzych
Country [396] 0 0
Poland
State/province [396] 0 0
Warszawa
Country [397] 0 0
Poland
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Wejherowo
Country [398] 0 0
Poland
State/province [398] 0 0
Wloclawek
Country [399] 0 0
Poland
State/province [399] 0 0
Wroclaw
Country [400] 0 0
Poland
State/province [400] 0 0
Zamosc
Country [401] 0 0
Portugal
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Amadora
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Portugal
State/province [402] 0 0
Aveiro
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Portugal
State/province [403] 0 0
Braga
Country [404] 0 0
Portugal
State/province [404] 0 0
Coimbra
Country [405] 0 0
Portugal
State/province [405] 0 0
Leiria
Country [406] 0 0
Portugal
State/province [406] 0 0
Lisboa
Country [407] 0 0
Portugal
State/province [407] 0 0
Penafiel
Country [408] 0 0
Portugal
State/province [408] 0 0
Santa Maria Da Feira
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Portugal
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Santarem
Country [410] 0 0
Portugal
State/province [410] 0 0
Setubal
Country [411] 0 0
Portugal
State/province [411] 0 0
Vila Nova de Gaia
Country [412] 0 0
Portugal
State/province [412] 0 0
Vila Real
Country [413] 0 0
Puerto Rico
State/province [413] 0 0
San Juan
Country [414] 0 0
Romania
State/province [414] 0 0
Arges
Country [415] 0 0
Romania
State/province [415] 0 0
Cluj
Country [416] 0 0
Romania
State/province [416] 0 0
Braila
Country [417] 0 0
Romania
State/province [417] 0 0
Brasov
Country [418] 0 0
Romania
State/province [418] 0 0
Bucharest
Country [419] 0 0
Romania
State/province [419] 0 0
Buzau
Country [420] 0 0
Romania
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Craiova
Country [421] 0 0
Romania
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Iasi
Country [422] 0 0
Romania
State/province [422] 0 0
Suceava
Country [423] 0 0
Russian Federation
State/province [423] 0 0
Khanty-mansiysk Autonomous Dis
Country [424] 0 0
Russian Federation
State/province [424] 0 0
Barnaul
Country [425] 0 0
Russian Federation
State/province [425] 0 0
Ekaterinburg
Country [426] 0 0
Russian Federation
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Irkutsk
Country [427] 0 0
Russian Federation
State/province [427] 0 0
Kaliningrad
Country [428] 0 0
Russian Federation
State/province [428] 0 0
Kazan
Country [429] 0 0
Russian Federation
State/province [429] 0 0
Kemerovo
Country [430] 0 0
Russian Federation
State/province [430] 0 0
Krasnodar
Country [431] 0 0
Russian Federation
State/province [431] 0 0
Krasnoyarsk
Country [432] 0 0
Russian Federation
State/province [432] 0 0
Moscow
Country [433] 0 0
Russian Federation
State/province [433] 0 0
Murmansk
Country [434] 0 0
Russian Federation
State/province [434] 0 0
Nizhniy Novgorod
Country [435] 0 0
Russian Federation
State/province [435] 0 0
Novosibirsk
Country [436] 0 0
Russian Federation
State/province [436] 0 0
Rostov-na-donu
Country [437] 0 0
Russian Federation
State/province [437] 0 0
Samara
Country [438] 0 0
Russian Federation
State/province [438] 0 0
St. Petersburg
Country [439] 0 0
Russian Federation
State/province [439] 0 0
Tomsk
Country [440] 0 0
Russian Federation
State/province [440] 0 0
Tyumen
Country [441] 0 0
Russian Federation
State/province [441] 0 0
Vladivostok
Country [442] 0 0
Singapore
State/province [442] 0 0
Singapore
Country [443] 0 0
Slovakia
State/province [443] 0 0
Bratislava
Country [444] 0 0
Slovakia
State/province [444] 0 0
Kosice
Country [445] 0 0
Slovakia
State/province [445] 0 0
Liptovsky Mikulas
Country [446] 0 0
Slovakia
State/province [446] 0 0
Martin
Country [447] 0 0
Slovakia
State/province [447] 0 0
Nitra
Country [448] 0 0
Slovakia
State/province [448] 0 0
Nove Zamky
Country [449] 0 0
Slovakia