Preventing recurrent strokes with a combination blood pressure pill

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Hospital of Sri Lanka
  Colombo, Sri Lanka Recruiting
• Karapitiya Teaching Hospital
  Galle, Sri Lanka Recruiting
• Jaffna Teaching Hospital
  Jaffna, Sri Lanka Recruiting
• Teaching Hospital Kurunegala
  Kurunegala, Sri Lanka Recruiting
• Ragama Teaching Hospital
  Ragama, Sri Lanka Recruiting
• Liverpool Hospital
  Liverpool, New South Wales, Australia Active not recruiting

+15 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Craig Anderson — The George Institute
• Study coordinator: Natalie Espinosa
• Email: nespinosa@georgeinstitute.org.au
• Phone: +61 2 8052 4561

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.