brain haemorrhage Intracerebral haemorrhage
Conditions
Interventions
All participants who meet the eligibility criteria for the study will be 
randomized to: 
1. Active treatment: encapsulation of generic regulatory approved combination 
of low doses of telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg 
(*Triple Pill*), or
 
2. Control: encapsulation of 3 placebo tablets.
Sponsors
The George Institute for Global Health - Australia
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adults (>=18 years) with a history stroke due to primary intracerebral haemorrhage (ICH) confirmed by brain imaging, 2. Clinically stable, as judged by investigator, 3. Two resting systolic BP (SBP) levels, measured 5 minutes apart in the range 130-160mmHg recorded in a seated position., 4. Provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Taking an ACE inhibitor antihypertensive drug that cannot be switched to any of the following alternatives:, - telmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25, or;, - an equivalent class (angiotensin receptor blocker, calcium channel blocker, or thiazide-like diuretic), or;, - a beta-blocker, 2. Contraindication to any of the study medications, in the context of currently prescribed BP 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 contraception, 5. Any condition that in the opinion of the responsible physician or investigator that renders the patient unsuitable for the study (e.g. severe disability (ie modified Rankin Scale [mRS] score of 4-5] or significant memory or behavioural disorder or hyperkalaemia and/or hyponatremia, defined by local lab criteria)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Primary outcome: Time to first occurrence of recurrent stroke, whether ischaemic or ICH. - Secondary outcomes: Recurrent ICH; ischaemic stroke; fatal or disabling stroke; mortality; MACE [major adverse CV events of CV death, non-fatal myocardial infarction, or non-fatal stroke]; health-related quality of life [HRQoL] using the EuroQoL Group 5-Dimension Self-Report Questionnaire [EQ-5D]; physical function (simplified modified Rankin scale [smRS]); cognitive impairment, defined by standard cut-points on the Montreal Cognitive Assessments [MoCA]. | — |
Secondary
| Measure | Time frame |
|---|---|
| see item primary study parameters/outcome of the study. | — |
Countries
Netherlands
Outcome results
None listed