Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT): Effect of intensive blood pressure lowering treatment provided by a Triple Pill strategy on the time to first occurrence of recurrent stroke in patients with a history of acute stroke due to intracerebral haemorrhage.

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 acute stroke due to intracerebral hemorrhage.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2017/030

Enrollment

Unknown

Registered

2017-09-19

Start date

2017-09-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke caused by Intracerebral Hemorrhage (ICH), Hypertension

Interventions

1. Study sites • National Hospital of Sri Lanka • Sri Jayewardenepura General Hospital • Colombo North Teaching Hospital, Ragama • Kurunegala Teaching Hospital • Peradeniya Teaching Hospital • Kandy T

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female adults (>18 years) with a history of up to 6 months after symptom onset of primary ICH that is confirmed by imaging (copy of the brain imaging report to be submitted to the Central Coordinating Centre (CCC) labelled with study ID and with personal identifiers removed) 2. Clinically stable, as judged by investigator 3. Two resting systolic blood pressure (SBP) levels measured 5 minutes apart in the range 130-160mmHg recorded in a seated position (Patients with higher SBP can be included if considered by attending clinician that management is consistent with local standards of clinical practice) 4. Geographical proximity to the recruiting hospital and/or follow-up medical clinic site to allow ready access for in-person clinic visits during follow-up 5. Provision of written informed consent

Exclusion criteria

Exclusion criteria: 1. Taking an ACE-I that cannot be switched to any of the following alternatives: • telmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25 or 2.5mg, or • an equivalent class (ARB, CCB or thiazide-like diuretic), or • a beta-blocker 2. Contraindication to any of the study medications, in the context of currently prescribed lowering medication 3. Unlikely/unable to complete the study procedures and/or follow-up 4. Females of child bearing age and capability, who are pregnant or breast-feeding, or those not Using adequate birth control

Design outcomes

Primary

Measure	Time frame
The time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic, assessed by patient and/or clinical report verified by medical documentation of stroke symptoms and imaging. [6 monthly from commencement for a total of 3 years]	—

Secondary

Measure	Time frame
Recurrent ICH, ischaemic stroke, fatal or disabling stroke, mortality [6 monthly from commencement for a total of 3 years] MACE (major adverse cardiovascular [CV] events of CV death, non-fatal myocardial infarction, or non-fatal stroke) [6 monthly from commencement for a total of 3 years] Health-related quality of life (HRQoL) using the EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D) [6 monthly from commencement for a total of 3 years] Physical function (simplified modified Rankin scale [smRS]), [6 monthly from commencement for a total of 3 years] Cognitive impairment, defined by standard cut-points on the Montreal Cognitive Assessments (MoCA), and supplemented by the Brief Memory and Executive Test. [6 monthly from commencement for a total of 3 years]	—

Measure

Time frame

Recurrent ICH, ischaemic stroke, fatal or disabling stroke, mortality [6 monthly from commencement for a total of 3 years] MACE (major adverse cardiovascular [CV] events of CV death, non-fatal myocardial infarction, or non-fatal stroke) [6 monthly from commencement for a total of 3 years] Health-related quality of life (HRQoL) using the EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D) [6 monthly from commencement for a total of 3 years] Physical function (simplified modified Rankin scale [smRS]), [6 monthly from commencement for a total of 3 years] Cognitive impairment, defined by standard cut-points on the Montreal Cognitive Assessments (MoCA), and supplemented by the Brief Memory and Executive Test. [6 monthly from commencement for a total of 3 years]

—

Countries

Australia,Japan,Netherlands,Sri Lanka,Taiwan, Province of China,United Kingdom

Contacts

Public ContactDr Bimsara Senanayake

Consultant Neurologist

bimsaras@sltnet.lk

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026