Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial: Rationale, design and progress

Craig S Anderson1,2,3,4, Anthony Rodgers1, H Asita de Silva5,6

  • 1The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.

Insights

A low-dose triple pill combination of blood pressure medications may improve outcomes for patients after intracerebral hemorrhage (ICH). This strategy aims to prevent recurrent stroke and cardiovascular events in high-risk individuals.

Area of Science:

  • Neurology
  • Cardiology
  • Clinical Trials

Background:

  • Intracerebral hemorrhage (ICH) survivors face a high risk of recurrent events and cardiovascular complications.
  • Optimizing secondary prevention is crucial for improving patient outcomes.
  • Single-pill combinations (SPCs) offer a simplified approach to managing blood pressure (BP).

Purpose of the Study:

  • To evaluate the efficacy of a novel SPC, the "Triple Pill," in preventing recurrent stroke, cardiovascular events, and cognitive impairment after ICH.
  • To assess the safety and tolerability of the Triple Pill regimen.

Main Methods:

  • An international, double-blind, placebo-controlled, randomized trial (TRIDENT) involving 1500 adults with ICH and mild-moderate hypertension.
  • Participants received either the Triple Pill (low-dose telmisartan, amlodipine, indapamide) or a placebo.
  • Follow-up averaged 3 years, with primary outcome being any stroke.

Main Results:

  • Recruitment began in September 2017, with 821 patients randomized by October 2021 across 54 sites in 10 countries.
  • Adherence to the Triple Pill regimen was 86% at 30 months.
  • The study is projected to achieve its required sample size by 2024.

Conclusions:

  • Low-dose Triple Pill blood pressure lowering demonstrates potential for improving long-term outcomes in ICH survivors.
  • This simplified therapeutic strategy warrants further investigation for secondary prevention in ICH patients.
Abstract

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