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Preventing recurrent strokes with a combination blood pressure pill

Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT), Substudies: MRI, Cognitive

Phase 3 Interventional The George Institute · NCT02699645

This study is testing if a new combination blood pressure pill can help prevent strokes in people who have had a brain bleed and have slightly high blood pressure.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1600 (estimated)
Ages18 Years and up
SexAll
SponsorThe George Institute Academic / other
Locations65 sites (Liverpool, New South Wales and 64 other locations)
Trial IDNCT02699645 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of a fixed low-dose combination blood pressure lowering pill, known as the 'Triple Pill', in preventing recurrent strokes in patients with a history of intracerebral haemorrhage (ICH) and mild hypertension. It is a multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial. The study aims to determine if more intensive blood pressure control can improve outcomes for these high-risk patients. Participants will receive either the Triple Pill or a placebo in addition to standard care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed history of primary intracerebral haemorrhage and mild hypertension.

Not a fit: Patients who are currently taking an ACE inhibitor that cannot be switched to the study medications may not benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of recurrent strokes in patients with a history of intracerebral haemorrhage.

How similar studies have performed: Other studies have shown promising results with similar blood pressure management strategies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adults (≥18 years) with a history of primary ICH that is confirmed by imaging (copy of the brain imaging report to be uploaded to the database, labelled with participant identification (ID) and with personal identifiers removed)
* Clinically stable, as judged by investigator
* Average of two resting SBP levels measured 5 minutes apart in the range 130-160mmHg recorded in a seated position (National Heart Foundation of Australia Guidelines). (Patients with higher SBP can be included if considered by attending clinician that management is consistent with local standards of clinical practice)
* 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
* No clear contraindication to any of the study treatments
* Provision of written informed consent

Exclusion Criteria:

* Taking an ACE-I that cannot be switched to any of the following alternatives:

  * telmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25mg, or
  * an equivalent class (ARB, CCB or thiazide \[TZ\]-like diuretic), or
  * a BB
* Contraindication to any of the study medications, in the context of currently prescribed BP-lowering medication
* Unable to complete the study procedures and/or follow-up
* Females of child-bearing age and capability, who are pregnant or breast-feeding, or those of child-bearing age and capability who are not using adequate birth control
* Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsible physician
* Estimated glomerular filtration rate (eGFR) \<30mL/min/1.73m2
* Severe hepatic impairment (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>3x the upper limit of normal \[ULN\])
* Any other condition that in the opinion of the responsible physician or investigator renders the patient unsuitable for the study (e.g. severe disability \[i.e. simplified modified Rankin Scale (smRS) of 4-5\] or significant memory or behavioural disorder)

Exclusion Criteria for MRI (as applies)

• Any MRI contraindication (e.g. metallic implants, claustrophobia, etc) or participant refusal.

Where this trial is running

Liverpool, New South Wales and 64 other locations

+15 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Intracerebral HaemorrhageHypertensionBlood PressureStroke
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.