Sri Lanka contributed 70% data in the 12-country TRIDENT trial, with the Clinical Trials Unit of the University of Kelaniya coordinating the country’s participation

The TRIDENT international clinical trial, led in Sri Lanka by the Clinical Trials Unit at the Faculty of Medicine, University of Kelaniya Sri Lanka, has shown that a 𝗼𝗻𝗰𝗲-𝗱𝗮𝗶𝗹𝘆 𝘁𝗵𝗿𝗲𝗲-𝗶𝗻-𝗼𝗻𝗲 𝗹𝗼𝘄-𝗱𝗼𝘀𝗲 𝗯𝗹𝗼𝗼𝗱 𝗽𝗿𝗲𝘀𝘀𝘂𝗿𝗲 𝗽𝗶𝗹𝗹 can reduce recurrent stroke risk by 40% and recurrent intracerebral haemorrhage risk by 60% in survivors of ICH.

The trial was delivered by RemediumOne, coordianting the trial management activities across all participating centres in Sri Lanka.

The results of the trial were published in the The New England Journal of Medicine on 23rd April 2026. Of the 1,670 patients studied in the TRIDENT trial, 𝗮𝗹𝗺𝗼𝘀𝘁 𝟳𝟬% 𝗼𝗳 𝗱𝗮𝘁𝗮 𝘄𝗮𝘀 𝗴𝗲𝗻𝗲𝗿𝗮𝘁𝗲𝗱 𝗳𝗿𝗼𝗺 𝟭𝟭 𝗵𝗼𝘀𝗽𝗶𝘁𝗮𝗹𝘀 𝗮𝗰𝗿𝗼𝘀𝘀 𝗦𝗿𝗶 𝗟𝗮𝗻𝗸𝗮.

“Clinical trials conducted by us with Sri Lankan clinicians and international collaborators during the last 10 years have shown a triple low-dose combination of blood pressure lowering drugs in a single pill is a very strong approach to control blood pressure compared to routine approaches in clinical practice today. This new drug was recently approved by the US Food and Drug Administration to treat high blood pressure and included in the WHO model list of essential medicines recently for countries to adopt. We have now very clearly shown sustained and long-term control of blood pressure with this approach can reduce the risk of recurrent stroke dramatically. This is a game changer,” said Professor Asita de Silva, the national lead of TRIDENT for Sri Lanka.

He added that the strong Sri Lankan contribution to the trial also demonstrated the country’s growing role in global medical research.

“Almost 70 per cent of the data for TRIDENT was generated from Sri Lanka. In addition to the local relevance of trial results and the quality of data that supports generalizability of findings to other countries, this is another example of how well Sri Lankan clinicians and clinical researchers can contribute to improving global health,” he said.

Dr Bimsara Senanayake, Specialist Neurologist and Lead Investigator at the National Hospital of Sri Lanka told, “Very limited treatment options for intracerebral haemorrhage, uncertainty about the effectiveness of more-intensive blood pressure control, and how best to do it have remained unresolved for decades, and I think the TRIDENT trial now gives all of that information for us to implement in our clinical practice. The findings are especially significant because patients who survive this type of brain bleed face a heightened risk of another catastrophic event in the years that follow. The better blood pressure control we can achieve in intracerebral haemorrhage, the better for the patients.”

Prof Jeyaraj Pandian, President of the World Stroke Organisation, described the TRIDENT findings as a major advance in stroke prevention. “TRIDENT is a major advance in showing the enormous benefits of effective blood pressure control after an intracerebral haemorrhage,” he said.

President of the Association of Sri Lankan Neurologists and one of the study authors, Dr Ajantha Keshavaraj said: ‘Our results have the potential to mark a real shift in how we manage blood pressure following a stroke. This novel treatment along with lifestyle changes such as reduced salt intake could save thousands of lives by preventing repeat strokes”.

We would like to thank The George Institute for Global Health and Prof Craig Anderson, who led the trial with funding from the National Health and Medical Research Council (NHMRC) and the Brazilian Ministry of Health.

Importantly, this same triple-pill was the first of its kind to be included in the World Health Organization’s List of Essential Medicines for high blood pressure. This triple-pill concept initially emerged from research in Sri Lanka involving patients with high blood pressure, which showed 70% achievement of blood pressure control.

What the TRIDENT trial found

The TRIDENT study enrolled patients who had experienced ICH and had systolic blood pressure between 130 and 160 mmHg. Participants received either the triple pill, telmisartan 20 mg, amlodipine 2.5 mg, and indapamide 1.25 mg or a placebo, in addition to standard care. The average follow-up period was three years, with a maximum of seven years.

Key results:

— 4.6% of patients in the treatment group experienced a recurrent stroke, compared with 7.4% in the placebo group, representing a 39% reduction in risk.

— The risk of a repeat ICH specifically fell by 60%.

— One stroke was prevented for every 35 patients treated.

— Patients on the triple pill had average systolic blood pressure approximately 9 mmHg lower than those on placebo.

— Major cardiovascular events, including non-fatal stroke, non-fatal heart attack, and cardiovascular death fell by 33%.

Sri Lanka bears a substantial burden of stroke, with an estimated 60,000 people experiencing a stroke each year, while cardiovascular disease accounts for over 40% of all deaths nationally. High blood pressure affecting around 40% of Sri Lankan remains the leading modifiable risk factor for stroke. Given that nearly 70% of TRIDENT participants were recruited from Sri Lanka, the trial’s findings are especially relevant to local clinical practice and have important implications for reducing recurrent stroke and cardiovascular risk across the country.

Access the paper here: https://www.nejm.org/doi/full/10.1056/NEJMoa2515043