Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT): Effect of intensive blood pressure lowering treatment provided by a Triple Pill strategy on the time to first occurence of recurrent stroke in patients with a history of acute stroke due to intracerebral haemorrhage.

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1800

Inclusion Criteria

•Adults (greater than or equal to 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 [NHF] 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
otelmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25mg, or
oan equivalent class (ARB, CCB or thiazide [TZ]-like diuretic), or
oa beta-blocker (BB)
•Contraindication to any of the study medications, in the context of currently prescribed BP-lowering medication

Exclusion Criteria for MRI (as applies)
• Any MRI contraindication (e.g. metallic implants, claustrophobia, etc) or participant refusal
•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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic, assessed by patient and/or clinical report verified by medical documentation of stroke symptoms and imaging.[ Reviewed 6-monthly; participant follow-up, 6 years<br>]

Secondary Outcome Measures