drugset / Trial / NCT03783754

Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Magnetic Resonance Imaging Sub-study

NCT03783754

RandomizedParallel-groupTriple-blindScreening

Summary

TRIDENT Main Study: TRIDENT is a multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial of a fixed low-dose combination BP-lowering pill ("Triple Pill") strategy on top of standard of care, in patients with a history of acute intracerebral haemorrhage (ICH) and systolic blood pressure (SBP) levels defined as 'high normal to borderline high', and on either minimal or no BP-lowering treatment according to current guidelines. MRI Sub-Study Centres capable of specific MRI of the brain sequences will be identified. The patients in the TRIDENT main study who are identified to be eligible for the MRI Sub-Study will undergo MRI scans at baseline (6 weeks to 6 months post-randomisation) and at 36-month follow-up time points. All data collected will be analysed centrally at the Brain and Mind Centre (BMC) in Sydney, Australia.

Timeline

Start
2018-08-09
Primary completion
2021-03-21
Completion
2021-03-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 2.5 mg
Subject Indapamide Small molecule 1.25 mg
Subject Telmisartan Other / unclassified 20 mg