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; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 654

Inclusion Criteria

1. Age = 18 years
2. Ability to provide informed consent
3. Recent history of a non-traumatic spontaneous ICH within 15 days to 6 months before enrolment
4. Presence of AF (paroxysmal, persistent, permanent)
5. CHA2DS2-VASc score =2 for male and CHA2DS2-VASc score =3 for female patients [15].
6. Availability of a brain scan performed after the ICH and before enrolment
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

1. Patient lacks the capacity to consent
2. Fully dependent (modified Rankin scale >4)
3. Women who are pregnant, breastfeeding or planning on becoming pregnant
4. Women of childbearing potential (WOCBP 12.1) who are unable or unwilling to take measures for effective contraception (4.8)
5. ICH occurring within the last 14 days before enrolment
6. ICH occurring longer than 6 months before enrolment
7. ICH resulting from trauma or vascular malformation
8. Indication for long-term anticoagulation other than AF
9. Patient has hypertension, which in the opinion of the investigator, is uncontrollable with medication
10. Any contraindication (except intracerebral haemorrhage) to treatment with apixaban, dabigatran, edoxaban, rivaroxaban as per Summary of Product Charasteristics (SmPC)
11. Absolute need for antiplatelet therapy at enrolment
12. Presence of a left atrial appendage occlusion device (LAAO) or plan to implant an LAAO
13. 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
14. 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