Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study
NCT03785067 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2021-04-01
Summary
A Sub-Study of an investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial (TRIDENT) to determine the effect of more intensive long-term blood pressure control, provided by a fixed low-dose combination blood pressure lowering pill ("Triple Pill") strategy on top of standard of care, for slowing memory decline as measured by Cambridge Neuropsychological Test Automated Battery (CANTAB), in patients with a history of acute stroke due to intracerebral haemorrhage (ICH).
Conditions
- Cognitive Decline
- Intracerebral Hemorrhage
- Dementia, Vascular
- Cerebral Small Vessel Diseases
- Hypertension
- Stroke Hemorrhagic
Interventions
- DRUG
-
telmisartan 20mg + amlodipine 2.5mg +indapamide 1.25mg
1 capsule taken orally once daily for 36 months
- DRUG
-
Placebo oral capsule
1 capsule taken orally once daily for 36 months
Sponsors & Collaborators
-
University of Sydney
collaborator OTHER -
The George Institute
lead OTHER
Principal Investigators
-
Prof Craig Anderson · The George Institute
-
Prof Sharon Naismith · University of Sydney
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-27
- Primary Completion
- 2021-02-03
- Completion
- 2021-02-03
Countries
- Australia
- Netherlands
Study Locations
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