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.

Phase 3

Recruiting

• Conditions: Acute Intracerebral Haemorrhage, Hypertension

• Registration Number: PACTR201907745723209
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4200

Inclusion Criteria

• Adults (=18 years) with a history of up to 6 months after symptom onset of primary ICH confirmed by imaging (copy of the brain imaging report to be submitted to the CCC labelled with study ID and with personal identifiers removed)
• Clinically stable, as judged by investigator
• 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 it is 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 1.25 or 2.5mg, or
oan equivalent class (ARB, CCB or thiazide-like diuretic), or
oa 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 not using adequate birth control
•Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsible physician
•Estimated glomerular filtration rate (eGFR) <30 mL/min
•Severe hepatic impairment (ALT or AST >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)

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.