Prevention of Stroke in Survivors of Brain Bleeding with Atrial Fibrillatio

Phase 1

• Conditions: Ischaemic stroke prevention in patients with atrial fibrillation and previous intracerebral haemorrhage; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 21.1Level: LLTClassification code 10067816Term: Cardioembolic strokeSystem Organ Class: 100000004852; MedDRA version: 20.1Level: LLTClassification code 10055815Term: Haemorrhage intracerebralSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-002176-41-FR
• Lead Sponsor: Imperial College of Science, Technology and Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-08
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 654

Inclusion Criteria

1. Age = 18 years
2. Written informed consent
3. Recent history of a non-traumatic spontaneous ICH during the 6 months before enrolment
4. Documented evidence of AF (paroxysmal, persistent or permanent)
CHA2DS2-VASc score=2 for male, and CHA2DS2-VASc score= 3 for female patients
5. Availability of brain imaging following the index Intracerebral Haemorrhage (ICH)
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 554

Exclusion Criteria

•Patient lacks the capacity to consent
•Fully dependent (modified Rankin scale >4)
•Women who are pregnant, breastfeeding or planning on becoming pregnant
•Women of childbearing potential (WOCBP 12.1) who are unable or unwilling to take measures for effective contraception (4.8)
•ICH occurring within the last 14 days before enrolment
•ICH occurring longer than 6 months before enrolment
•ICH resulting from trauma or vascular malformation
•Indication for long-term anticoagulation other than AF
•Patient has hypertension, which in the opinion of the investigator, is uncontrollable with medication
•Any contraindication (except intracerebral haemorrhage) to treatment with apixaban, dabigatran, edoxaban, rivaroxaban as per Summary of Product Charasteristics (SmPC). Special warnings and precautions for use for apixaban, dabigatran, edoxaban, rivaroxaban as per SmPC should also be taken into account at randomization.”
•Absolute need for antiplatelet therapy at enrolment except aspirin or clopidogrel
•Presence of a left atrial appendage occlusion device (LAAO) or plan to implant an LAAO
•Presence of any medical, psychological, or psychiatric condition which in the opinion of the Principal or Co-Investigator would cause participation in the Study to be unwise
•Participation in any clinical study with an Investigational Medicinal Product within the past 30 days (observational studies are permitted)

Study & Design

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