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: 22.1Level: 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-AT
• 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: 2019-05-10
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 654

Inclusion Criteria

1. Age = 18 years
2. Written informed consent obtained from the patient, or for patients who lack the capacity to consent this can be provided by an appropriate representative
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)
6. Non-traumatic spontaneous ICH within the 12 months before enrolment. Patients become eligible for 14 days after the date of their 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

1. Fully dependent (defined as a modified Rankin Scale score of over 4)
2. Women who are pregnant, breastfeeding, or plan to become pregnant during the Study period
3. Women of childbearing potential (WOCBP) who are unable or unwilling to take measures for effective contraception
4. ICH occurring before 14 days after the date of ICH
5. ICH occurring longer than 12 months before enrolment
6. ICH resulting from trauma or vascular malformation
7. Another indication for long-term anticoagulation
8. Contraindication for long-term anticoagulant therapy with DOACs (other than ICH)
9. Absolute need for antiplatelet therapy at enrolment
10. Presence of a left atrial appendage occlusion device (LAAO) or plan to implant an LAAO
11. 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
12. 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