SLCTR/2017/030RecruitingPhase 3
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.
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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