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Trial registered on ANZCTR
Registration number
ACTRN12616000327482
Ethics application status
Approved
Date submitted
7/03/2016
Date registered
11/03/2016
Date last updated
22/04/2020
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT): Effect of intensive blood pressure lowering treatment provided by a Triple Pill strategy on the time to first occurence of recurrent stroke in patients with a history of acute stroke due to intracerebral haemorrhage.
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Scientific title
An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial to determine the effect of more intensive blood pressure control provided by a fixed low-dose combination blood pressure lowering pill (“Triple Pill”) strategy on top of standard of care, on the on time to first occurrence of recurrent stroke in patients with a history of acute stroke due to intracerebral haemorrhage (TRIDENT).
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Secondary ID [1]
288692
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None
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Secondary ID [2]
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ClinicalTrials.gov Identifier: NCT02699645
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Universal Trial Number (UTN)
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Trial acronym
TRIDENT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke caused by Intracerebral Haemorrhage (ICH)
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Hypertension
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Condition category
Condition code
Stroke
298073
298073
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0
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Haemorrhagic
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Cardiovascular
298123
298123
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0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Triple Pill (active treatment) - telmisartan 20mg, amlodipine 2.5mg and indapamide 1.25mg; taken orally, once daily for 36 months. Medication adherence and accountability is monitored through self-reports of doses missed and pill counts at every visit until end of treatment (Visits 3-9)
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Intervention code [1]
294117
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Treatment: Drugs
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Comparator / control treatment
Placebo - commonly used excipients (to be determined) received via blinded study capsules
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic, assessed by patient and/or clinical report verified by medical documentation of stroke symptoms and imaging.
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Timepoint [1]
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Reviewed 6-monthly; patient follow up, 3 years
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Secondary outcome [1]
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Recurrent ICH, assessed by patient and/or clinical report verified by medical documentation of stroke symptoms and imaging
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Timepoint [1]
321515
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Reviewed 6-monthly; patient follow up, 3 years
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Secondary outcome [2]
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Ischaemic Stroke, assessed by patient and/or clinical report verified by medical documentation of stroke symptoms and imaging.
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Timepoint [2]
321623
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Reviewed 6-monthly; patient follow up, 3 years
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Secondary outcome [3]
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Fatal or disabling stroke, assessed by patient and/or clinical report verified by medical documentation of stroke symptoms and imaging.
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Timepoint [3]
321624
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Reviewed 6-monthly; patient follow up, 3 years
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Secondary outcome [4]
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Mortality, assessed by review of medical records
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Timepoint [4]
321625
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Reviewed 6-monthly; patient follow up, 3 years
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Secondary outcome [5]
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Occurrence of MACE (major adverse CV events - CV death, non-fatal myocardial infarction, or non-fatal stroke), assessed by patient report verified by medical records and investigations
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Timepoint [5]
321626
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Reviewed 6-monthly; patient follow up, 3 years
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Secondary outcome [6]
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Physical function assessed by Modified Rankin Scale (mRS) assessed during follow up clinic visits
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Timepoint [6]
321627
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Reviewed 6-monthly; patient follow up, 3 years
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Secondary outcome [7]
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Change in systolic blood pressure (BP) assessed by sphygmomanometer during follow up clinic visits
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Timepoint [7]
321628
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Reviewed 6-monthly; patient follow up, 3 years
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Secondary outcome [8]
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Health-related Quality of Life (HRQoL) according to the EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D) assessed during follow up clinic visits
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Timepoint [8]
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Reviewed 6-monthly; patient follow up, 3 years
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Secondary outcome [9]
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Cognitive impairment, overall defined by standard cut-points on the Montreal Cognitive Assessment (MoCA), and supplemented with the Brief Memory & Executive Test (BMET)
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Timepoint [9]
321630
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Reviewed 6-monthly; patient follow up, 3 years
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Secondary outcome [10]
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Medical adherence assessed by self-reported measures and pill counts
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Timepoint [10]
321631
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Reviewed 6-monthly; patient follow up, 3 years
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Eligibility
Key inclusion criteria
• Adults ( greater than or equal to 18 years) with a history of up to 6 months after symptom onset of primary ICH that is confirmed by imaging (copy of the brain imaging report to be submitted to the CCC labelled with study ID and with personal identifiers removed)
• Clinically stable, as judged by investigator
• Two resting SBP levels measured 5 minutes apart in the range 130-160mmHg recorded in a seated position (Patients with higher SBP can be included if considered by attending clinician that management is consistent with local standards of clinical practice)
• Geographical proximity to the recruiting hospital and/or follow-up medical clinic site to allow ready access for in-person clinic visits during follow-up
• No clear contraindication to any of the study treatments
• Provision of written informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Gender
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Taking an ACE-I that cannot be switched to any of the following alternatives:
o telmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25 or 2.5mg, or
o an equivalent class (ARB, CCB or thiazide-like diuretic), or
o a beta-blocker
• Contraindication to any of the study medications, in the context of currently prescribed BP-lowering medication
• Unable to complete the study procedures and/or follow-up
• Females of child-bearing age and capability, who are pregnant or breast-feeding, or those not using adequate birth control
• Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsible physician
• Estimated glomerular filtration rate (eGFR) <30 mL/min
• Severe hepatic impairment (ALT or AST >3x the ULN)
• Any other condition that in the opinion of the responsible physician investigator renders the patient unsuitable for the study (e.g. severe disability [i.e. smRS of 4-5] or significant memory or behavioural disorder)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint(s)
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/09/2016
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Actual
7/09/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
4200
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Accrual to date
561
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,WA,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Liverpool Hospital - Liverpool
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Recruitment hospital [3]
10268
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Port Macquarie Base Hospital - Port Macquarie
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Recruitment hospital [4]
10270
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Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [5]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [6]
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [7]
14099
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Westmead Hospital - Westmead
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Recruitment hospital [8]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [9]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [10]
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Royal Brisbane & Womens Hospital - Herston
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Recruitment postcode(s) [1]
21933
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2050 - Camperdown
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Recruitment postcode(s) [2]
21934
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2170 - Liverpool
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Recruitment postcode(s) [3]
21935
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2444 - Port Macquarie
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Recruitment postcode(s) [4]
21937
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4575 - Birtinya
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Recruitment postcode(s) [5]
24216
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2065 - St Leonards
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Recruitment postcode(s) [6]
24217
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3050 - Parkville
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Recruitment postcode(s) [7]
26890
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2145 - Westmead
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Recruitment postcode(s) [8]
26891
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6150 - Murdoch
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Recruitment postcode(s) [9]
28801
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4102 - Woolloongabba
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Recruitment postcode(s) [10]
28802
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4029 - Herston
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Recruitment outside Australia
Country [1]
7646
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China
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State/province [1]
7646
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Country [2]
7647
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United Kingdom
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State/province [2]
7647
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Edinburgh, Nottingham, Hallifax, Kirkcaldy, Exeter, Glasgow, Stoke-on-Trent, Sheffield, Salford
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Country [3]
7649
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Brazil
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State/province [3]
7649
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Country [4]
7651
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Sri Lanka
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State/province [4]
7651
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Colombo, Nugegoda, Kurunegala, Peradeniya, Kandy, Ragama
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Country [5]
9236
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Malaysia
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State/province [5]
9236
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Country [6]
9237
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Taiwan, Province Of China
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State/province [6]
9237
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Country [7]
9238
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Netherlands
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State/province [7]
9238
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Nijmegen, Arnhem, Amsterdam, Maastricht. Zuyderland, Utrecht
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Country [8]
9654
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Switzerland
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State/province [8]
9654
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Bern, Zurich
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Country [9]
9655
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Viet Nam
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State/province [9]
9655
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Ho Chi Minh City
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Country [10]
9656
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Singapore
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State/province [10]
9656
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Country [11]
21646
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Nigeria
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State/province [11]
21646
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Ilorin, Shika Zaria, Jos, Lagos, Ibadan
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Country [12]
21647
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Georgia
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State/province [12]
21647
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Tbilisi
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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Level 1, 16 Marcus Clarke Street, Canberra ACT 2601
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Country [1]
293056
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Australia
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Primary sponsor type
Other
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Name
The George Institute for Global Health
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Address
Level 10 King George V Building, 83-117 Missenden Road, Camperdown, NSW 2050
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
291835
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Country [1]
291835
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Hospital (RPAH) Zone)
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Ethics committee address [1]
294564
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Royal Prince Alfred Hospital
Missenden Road, CAMPERDOWN, NSW, 2050
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Ethics committee country [1]
294564
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Australia
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Date submitted for ethics approval [1]
294564
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07/03/2016
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Approval date [1]
294564
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30/06/2016
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Ethics approval number [1]
294564
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16/RPAH/100
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Summary
Brief summary
Acute intracerebral haemorrhage (ICH) is the most serious and least treatable form of stroke, accounting for at least 10% of the 20 million new strokes (including 50,000+ Australians) that occur in the world each year. Survivors of ICH are at high risk of recurrent ICH and other serious cardiovascular events. While there is strong evidence that this risk can be reduced by lowering the BP of patients after ICH, such as from the PROGRESS trial undertaken by several of the applicants, many patients with ICH do not receive blood pressure lowering and if they do, receive treatment so that their BP is inadequately controlled.
The aim of this study is to demonstrate the superiority of a combination of fixed low-dose generic BP lowering agents as a “Triple Pill” strategy on top of standard of care for the prevention of recurrent stroke in patients with a history of ICH and high normal or low grade hypertension in a large-scale, international, double-blind, placebo-controlled, randomised controlled trial.
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Trial website
www.tridentstudy.org
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Craig Anderson
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Address
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The George Institute for Global Health, Australia
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050
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Country
64150
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Australia
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Phone
64150
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+61 2 9993 4521
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Fax
64150
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Email
64150
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canderson@georgeinstitute.org.au
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Contact person for public queries
Name
64151
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Ms Ruth Freed
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Address
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The George Institute for Global Health, Australia
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050
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Country
64151
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Australia
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Phone
64151
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+61 2 9993 4522
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Fax
64151
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Email
64151
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rfreed@georgeinstitute.org.au
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Contact person for scientific queries
Name
64152
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Prof Craig Anderson
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Address
64152
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The George Institute for Global Health, Australia
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050
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Country
64152
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Australia
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Phone
64152
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+61 2 9993 4521
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Fax
64152
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Email
64152
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canderson@georgeinstitute.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
no IPD will be shared
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What supporting documents are/will be available?
No other documents available
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Summary results
No Results
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