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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02298088




Registration number
NCT02298088
Ethics application status
Date submitted
27/10/2014
Date registered
21/11/2014
Date last updated
15/02/2019

Titles & IDs
Public title
Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis
Scientific title
Phase III, Randomized, International, Multicenter, Open Label, With Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared With Clopidogrel in Patients With Acute Coronary Syndrome With ST Elevation Treated With Pharmacological Thrombolysis.
Secondary ID [1] 0 0
TREAT01
Universal Trial Number (UTN)
Trial acronym
TREAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute ST Segment Elevation Myocardial Infarction 0 0
Thrombolysis in Myocardial Infarction Flow 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor 180 mg
Treatment: Drugs - Clopidogrel

Active Comparator: Ticagrelor 180 mg - Patients assigned to Ticagrelor will receive oral Ticagrelor, 180 mg as early as possible after the index event and not >24 h post event followed by 90 mg twice daily for 12 months.

Active Comparator: Clopidogrel - Patients will take the 300 mg clopidogrel as early as possible after the index event and not > 24h post event, followed by 75mg/day for 12 months.
For patients with > 75 years the recommended load dose is 75 mg instead 300 mg.


Treatment: Drugs: Ticagrelor 180 mg
Ticagrelor, 180 mg as early as possible after the index event and not >24 h post event followed by 90 mg twice daily for 12 months.

Treatment: Drugs: Clopidogrel
300 mg clopidogrel as early as possible after the index event and not > 24h post event, followed by 75mg/day for 12 months.
For patients with > 75 years the recommended load dose is 75 mg instead 300 mg.

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

Outcomes
Primary outcome [1] 0 0
Safety Outcome as a measure of Time to TIMI-defined first major bleeding - The primary safety endpoint is time to TIMI-defined and adjudicated first major bleeding event (including major life-threatening bleeding and other major bleeding).
Bleeding TIMI Definition
Major:
Any intracranial hemorrhage (ICH)*, OR Clinically significant overt signs of hemorrhage associated with a drop in hemoglobin (Hgb) of = 5 g/dL (or, when Hgb is not available, an absolute drop in hematocrit (Hct) of = 15%).
An independent blinded central adjudication committee will adjudicate all suspected primary end points.
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Efficacy Outcome as a measure of major cardiovascular events - Secondary efficacy combined endpoint: death from vascular causes, myocardial infarction, stroke, severe recurrent ischemia, recurrent ischemia, TIA, or other arterial thrombotic event.
We will also measure the individual outcomes all-cause mortality and need for rescue PCI, as well as individual components of the combined efficacy endpoint.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Safety Outcome as a measure of bleeding event - Secondary safety endpoints: Total bleeding (major and minor) according to PLATO, TIMI and BARC definitions, minor bleeding according to the TIMI definition and major bleeding as individual endpoint according to the PLATO definition. Others safety variables will include: dyspnea, arrhythmia, bradycardia and laboratory safety tests
Timepoint [2] 0 0
12 months

Eligibility
Key inclusion criteria
- Patients of both sexes aged = 18 years and < 75 years with ACS with ST segment
elevation with onset during the previous 24 hours, documented by cardiac ischemic
symptoms due to atherosclerosis of > 10 minutes duration at rest, treated with
pharmacological thrombolysis

- Fibrinolytic therapy should be given to patients with STEMI and onset of ischemic
symptoms within the previous 12 hours

Patients with acute coronary syndrome with ST segment elevation will be included provided
they present ST segment elevation at the J point in two contiguous leads in
electrocardiogram with cut-points: > 0.1mV in all leads other than leads V2-V3, where the
following cut points apply: > 0.2 mV in men > 40 years; > 0.25 mV in men < 40 years, or
>0.15 mV in women and at least 1 of the following criteria:

- Angina-like chest pain or ischemic equivalent chest pain;

- Abnormalities above the reference value for markers of myocardial necrosis (troponin
and CK-MB).

The patient must be able to give informed consent in accordance with ICH GCP guidelines and
local legislation and/or regulations.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any contraindication against the use of clopidogrel (eg, hypersensitivity, moderate or
severe liver disease, active bleeding or bleeding history, history of intracranial
hemorrhage)

- Need for oral anticoagulation therapy,

- Concomitant oral or IV therapy with strong CYP3A inhibitors (ketoconazole,
itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir,
saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice N1 L/d), CYP3A
substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong
CYP3Ainducers (rifampin/rifampicin, phenytoin, carbamazepine)

- Increased risk of bradycardia events

- Dialysis required

- Known clinically important thrombocytopenia

- Known clinically important anemia

- Any other condition that may put the patient at risk or influence study results in the
investigators' opinion (eg, cardiogenic shock, severe hemodynamic instability, active
cancer)

- Participant in another investigational drug or device study within 30 d

- Pregnancy or lactation

- Any condition that increases the risk for noncompliance or being lost to follow-up

- Involvement in the planning or conduct of the study

- Previous enrollment or randomization in this study

- Contraindications to fibrinolytic therapy including: 15

- Any prior intracranial hemorrhage

- Known structural cerebral vascular lesion (eg, Arterial Venous Malformation -
AVM)

- Known malignant intracranial neoplasm (primary or metastatic)

- Ischemic stroke within 3 months

- Suspected aortic dissection

- Active bleeding or bleeding diathesis (excluding menses)

- Significant closed head trauma or facial trauma within 3 months

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
Open (masking not used)
Who is / are masked / blinded?



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)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Cairns Hospital - Cairns
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Mildura Hospital - Mildura
Recruitment hospital [6] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [7] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [8] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [9] 0 0
Townsville Hospital - Townsville
Recruitment hospital [10] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
- Adelaide
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- Cairns
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- Melbourne
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- Mildura
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- Newcastle
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- Perth
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- Sydney
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- Townsville
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- Wollongong
Recruitment outside Australia
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Argentina
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Bahia Blanca
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Florencio Varela
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La Plata
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Quilmes
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San Miguel de Tucuman
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Belo Horizonte
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Brasília
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Campinas
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Ipiau
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Manaus
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Messejana
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Brazil
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Porto Alegre
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Recife
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Teresina
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Funding & Sponsors
Primary sponsor type
Other
Name
Hospital do Coracao
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with
pharmacological thrombolysis
Trial website
https://clinicaltrials.gov/show/NCT02298088
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Otavio Berwanger, MD,PhD
Address 0 0
Hospital do Coracao
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications