Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial

Phase 1

• Conditions: Patients with a history of acute stroke due to Intracranial Haemorrhage with mild to moderately high blood pressure.; MedDRA version: 21.1Level: PTClassification code 10019016Term: Haemorrhagic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003724-23-NL
• Lead Sponsor: The George Institute for Global Health, University of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-31
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 4200

Inclusion Criteria

1. Adults (=18 years) up to 6 months after symptom onset of 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. No major contraindications to any of the study treatments.
5. Provision of written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2200

Exclusion Criteria

1. Taking an ACE inhibitor antihypertensive drug that cannot be switched to any of the following alternative medications:
o telmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25 or 2.5mg, or;
o an equivalent class (angiotensin receptor blocker, calcium channel blocker, or thiazide-like diuretic), or;
o 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. Significant hyperkalaemia and/or hyponatriemia, in the opinion of the responsible physician.
6. Estimated glomerular filtration rate (eGRF) < 30 mL/min.
7. Severe hepatic impairment (ALT or AST > 3x the upper limit of normal).
8. Any other 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified