Acute Intracerebral Haemorrhage, Hypertension
Conditions
Interventions
Triple Pill
Placebo
Sponsors
The George Institute for Global Health
Eligibility
Sex/Gender
All
Inclusion 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. (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
Exclusion criteria: • Taking an ACE-I that cannot be switched to any of the following alternatives: o telmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25 or 2.5mg, or o an equivalent class (ARB, CCB or thiazide-like diuretic), or o a beta-blocker • 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) 3x the upper limit of normal [ULN]) Any other conditions that in the opinion of the responsible physician or investigator that renders the patient unsuitable for the study (e.g. severe disability [i.e. smRS of 4-5] or significant memory or behavioural disorder)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrent ICH, assessed by patient and/or clinical report verified by medical documentation of stroke symptoms and imaging;Ischaemic Stroke, assessed by patient and/or clinical report verified by medical documentation of stroke symptoms and imaging;Fatal or disabling stroke, assessed by patient and/or clinical report verified by medical documentation of stroke symptoms and imaging.;Mortality, assessed by review of medical records;Occurrence of MACE (major adverse CV events - CV death, non-fatal myocardial infarction, or non-fatal stroke), assessed by patient report verified by medical records and investigations;Physical function assessed by Modified Rankin Scale (mRS) assessed during follow up clinic visits;Change in systolic blood pressure (BP) assessed by sphygmomanometer during follow up clinic visits;Health-related Quality of Life (HRQoL) according to the EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D) assessed during follow up clinic visits;Clinically significant cognitive impairment, overall defined by standard cut-points on the Montreal Cognitive Assessment (MoCA), and supplemented with the Brief Memory & Executive Test (BMET);Medical adherence assessed by self-reported measures and pill counts.; Depression, according to standard cut-point scores on the PHQ-9.;Cerebral small vessel disease defined by various standard markers on routine MRI, measured by individual components and overall CSVD burden. The primary measure of CSVD is FLAIR WMH volume. ;safety (serious adverse events [SAEs]); and tolerability (adverse events of special interest [AESI]) | — |
Countries
Nigeria
Contacts
Public ContactAdebukunola ;Ruth Telufusi; Freed
Executive Director CRO Xcene Research ;Senior Project Manager The George Institute for Global Health
Outcome results
None listed