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Clinical Trial Summary

An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial, to determine the effects of a fixed low-dose combination blood pressure lowering pill ("Triple Pill") on top of standard of care on blood pressure control, and on time to first occurrence of recurrent stroke, in patients with a history of acute intracerebral haemorrhage (TRIDENT).


Clinical Trial Description

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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02699645
Study type Interventional
Source The George Institute
Contact Grace Balicki
Phone +61 2 8052 4811
Email gbalicki@georgeinstitute.org.au
Status Recruiting
Phase Phase 3
Start date September 28, 2017
Completion date December 2023

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