Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial

Launched by THE GEORGE INSTITUTE · Mar 2, 2016

Keywords

ClinConnect Summary

The "Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial" is a clinical study aimed at understanding whether a specific blood pressure treatment can help prevent strokes in people who have previously experienced a type of brain bleed known as intracerebral hemorrhage (ICH). The study will test a combination pill, referred to as the "Triple Pill," which contains three different medications to lower blood pressure, in comparison to a placebo (a pill that has no active ingredients). Researchers are particularly interested in how this treatment affects the time until participants have another stroke.

To participate in this trial, individuals must be at least 18 years old and have a confirmed history of ICH. They should have stable health and specific blood pressure readings. Those with certain health conditions or taking specific medications may not be eligible. If you decide to join, you can expect regular check-ups and monitoring throughout the study. This trial is important because it could lead to better treatment options for preventing future strokes in people with a history of brain bleeds.

Gender

ALL

Eligibility 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.