Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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 stroke due to intracerebral haemorrhage.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Institute
• Collaborator: The University of New South Wales
• Treatments: Amlodipine; Indapamide; Telmisartan

Criteria

Inclusion Criteria:

• Adults (≥18 years) with a history of up to 12 months after symptom onset 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 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)