Home » Trials » SLCTR/2017/030
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 time to first occurrence of recurrent stroke in patients with a history of acute stroke due to intracerebral hemorrhage.
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SLCTR Registration Number
SLCTR/2017/030
Date of Registration
The date of last modification
Aug 24, 2019
Trial Status
Scientific Title of Trial
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 time to first occurrence of recurrent stroke in patients with a history of acute stroke due to intracerebral hemorrhage.
Public Title of Trial
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 occurrence of recurrent stroke in patients with a history of acute stroke due to intracerebral haemorrhage.
Disease or Health Condition(s) Studied
Stroke caused by Intracerebral Hemorrhage (ICH), Hypertension
Scientific Acronym
TRIDENT
Public Acronym
TRIDENT
Brief title
Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial(TRIDENT)
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
NCT02699645 (ClinicalTrials.gov), ANZCTR: 12616000327482 (Australian New Zealand Clinical Trials Registry)
What is the research question being addressed?
Can the superiority of a combination of fixed low-dose generic blood pressure lowering agents as a “Triple Pill” strategy on top of standard of care prevent recurrent stroke in patients with a history of ICH and high normal or low-grade hypertension?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 3
Intervention(s) planned
Study sites • National Hospital of Sri Lanka • Sri Jayewardenepura General Hospital • Colombo North Teaching Hospital, Ragama • Kurunegala Teaching Hospital • Peradeniya Teaching Hospital • Kandy Teaching Hospital • Colombo South Teaching Hospital
Method of randomization: via a secure web-based internet system. The randomization ratio will be 1:1, and will be stratified to ensure balance in prognostic factors: country of recruitment, age (<65 vs. >65 years) and average of 2 recorded baseline systolic BP measurements (<140 vs >140mmHg).
The double-blind period will be preceded by a single-blind (participants will remain blind), active run-in phase to ensure tolerability and adherence of the regimen. This will last a minimum of 2 weeks and may be extended for a further 2 weeks if the first period was interrupted, problematic or another reason (maximum 4 weeks run-in phase)
All randomized participants will receive study medication for an average of three years.
Interventions Experimental arm: Triple Pill (active treatment) telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg. 1 capsule taken orally once daily for 36 months
Placebo Comparator: Placebo Received via blinded study capsules. 1 capsule taken orally once daily for 36 months
Inclusion criteria
Male and female adults (>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 Central Coordinating Centre (CCC) labelled with study ID and with personal identifiers removed)
Clinically stable, as judged by investigator
Two resting systolic blood pressure (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
Provision of written informed consent
Exclusion criteria
Taking an ACE-I that cannot be switched to any of the following alternatives: • telmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25 or 2.5mg, or • an equivalent class (ARB, CCB or thiazide-like diuretic), or • a beta-blocker
Contraindication to any of the study medications, in the context of currently prescribed lowering medication
Unlikely/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
Primary outcome(s)
|
1.
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. |
[ 6 monthly from commencement for a total of 3 years ] |
Secondary outcome(s)
|
1.
Recurrent ICH, ischaemic stroke, fatal or disabling stroke, mortality |
[ 6 monthly from commencement for a total of 3 years ] |
|
2.
MACE (major adverse cardiovascular [CV] events of CV death, non-fatal myocardial infarction, or non-fatal stroke) |
[ 6 monthly from commencement for a total of 3 years ] |
|
3.
Health-related quality of life (HRQoL) using the EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D) |
[ 6 monthly from commencement for a total of 3 years ] |
|
4.
Physical function (simplified modified Rankin scale [smRS]), |
[ 6 monthly from commencement for a total of 3 years ] |
|
5.
Cognitive impairment, defined by standard cut-points on the Montreal Cognitive Assessments (MoCA), and supplemented by the Brief Memory and Executive Test. |
[ 6 monthly from commencement for a total of 3 years ] |
Target number/sample size
500 subjects from Sri Lanka (250 in each arm)
Countries of recruitment
Australia, Japan, Netherlands, Sri Lanka, Taiwan, Province of China, United Kingdom
Anticipated start date
2017-09-25
Anticipated end date
2023-08-01
Date of first enrollment
2017-10-17
Date of study completion
Recruitment status
Recruiting
Funding source
National Health and Medical Research Council (NHMRC) of Australia (Grant number: APP1103886)
Regulatory approvals
Approved (NMRA/SCOCT/CT/03?2017)
Status
Approved
Date of Approval
2017-03-14
Approval number
P/112/03/2017
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Bimsara Senanayake
Consultant Neurologist
National Hospital of Sri Lanka
Colombo 10
94773046096
bimsaras@sltnet.lk
Primary study sponsor/organization
The George Institute for Global Health
The University of Sydney
Level 10, King George V Building, 83-117 Missenden Rd
Camperdown NSW 2050 Australia
+61 2 8052 4500
+61 2 8052 4501
TRIDENT@georgeinsitute.org.au
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
