Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial

Phase 3

Recruiting

Conditions: brain haemorrhage
Intracerebral haemorrhage
10007963
10047075

Registration Number: NL-OMON54804

Lead Sponsor: The George Institute for Global Health - Australia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Primary outcome: Time to first occurrence of recurrent stroke, whether<br /><br>ischaemic or ICH.<br /><br>- Secondary outcomes: Recurrent ICH; ischaemic stroke; fatal or disabling<br /><br>stroke; mortality; MACE [major adverse CV events of CV death, non-fatal<br /><br>myocardial infarction, or non-fatal stroke]; health-related quality of life<br /><br>[HRQoL] using the EuroQoL Group 5-Dimension Self-Report Questionnaire [EQ-5D];<br /><br>physical function (simplified modified Rankin scale [smRS]); cognitive<br /><br>impairment, defined by standard cut-points on the Montreal Cognitive<br /><br>Assessments [MoCA]. </p><br>

Secondary Outcome Measures