NCT02699645

Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial

Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT), Substudies: MRI, Cognitive

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,671 (actual)
• Sponsor: The George Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 stroke due to intracerebral haemorrhage.

Detailed description

Intracerebral haemorrhage (ICH) is the most serious and least treatable form of stroke, accounting for at least 10% of the 20 million new strokes that occur globally 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 blood pressure (BP) of patients after ICH, many patients with ICH do not receive BP-lowering treatment long-term unless BP levels are particularly high, and many do not receive BP combination therapy. The aim of this study is to assess the safety and efficacy 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. The study is a large-scale, international, double-blind, placebo-controlled, randomised controlled trial.

Conditions

• Intracerebral Haemorrhage (ICH)
• Hypertension

Interventions

Type	Name	Description
DRUG	telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg	1 pill taken orally once daily for average of 72 months
DRUG	Placebo	1 pill taken orally once daily for average of 72 months

Timeline

• Start date: 2017-09-28
• Primary completion: 2025-08-27
• Completion: 2025-08-27
• First posted: 2016-03-04
• Last updated: 2025-09-12

Locations

58 sites across 10 countries: Australia, Brazil, Georgia, Malaysia, Netherlands, Nigeria, Singapore, Sri Lanka, Taiwan, United Kingdom