TRIDENT Study

The TRIDENT study, led by The George Institute for Global Health, represents a major international effort to evaluate whether an intensive, fixed low-dose Triple Pill blood pressure (BP), lowering strategy can prevent recurrent strokes in patients with a history of intracerebral hemorrhage (ICH). It is a multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial. ICH accounts for at least 10% of the 20 million strokes worldwide each year. Survivors of ICH face a significantly increased risk of recurrent stroke and other cardiovascular events.

TRIDENT study was conducted across multiple countries including Australia, Brazil, Georgia, Malaysia, Nigeria, The Netherlands, Singapore, Sri Lanka, Taiwan, and the United Kingdom, the study represents a major global effort to address unmet needs in stroke prevention

RemediumOne’s  team managed all aspects of trial delivery in Sri Lanka, including site activation, regulatory approvals, monitoring, and data coordination, ensuring high-quality execution in accordance with international standards.

Sites in Sri Lanka, includes:

National Hospital of Sri Lanka

Sri Jayewardenepura General Hospital

Colombo North Teaching Hospital, Ragama

Kurunegala Teaching Hospital

Peradeniya Teaching Hospital

Kandy Teaching Hospital

Colombo South Teaching Hospital

The study tests a novel Triple Pill approach (telmisartan 20mg + amlodipine 2.5mg + indapamide 1.25mg) to improve treatment adherence and efficacy. Participants were randomized 1:1, with stratification by country, age, and baseline blood pressure to maintain balance between groups. A unique feature of TRIDENT is its 2-4 week single-blind run-in phase, designed to confirm patient tolerance before full randomization. Over an average treatment period of three years, researchers will compare outcomes between patients receiving the Triple Pill versus placebo, with all participants continuing to receive standard-of-care treatment.

Recruitment for the study has been completed and the trial is currently in the follow-up phase.