Prevention of Stroke in intracerebral haemorrhage survivors with Atrial Fibrillatio
- Conditions
- Ischaemic stroke prevention in patients with atrial fibrillation and previous intracerebral haemorrhageMedDRA version: 20.0Level: LLTClassification code 10003661Term: Atrial fibrillation paroxysmalSystem Organ Class: 100000004849MedDRA version: 20.0Level: LLTClassification code 10034039Term: Paroxysmal atrial fibrillationSystem Organ Class: 100000004849MedDRA version: 20.0Level: LLTClassification code 10066551Term: Chronic atrial fibrillationSystem Organ Class: 100000004849MedDRA version: 20.0Level: LLTClassification code 10071668Term: Permanent atrial fibrillationSystem Organ Class: 100000004849MedDRA version: 22.1Level: LLTClassification code 10057613Term: Thromboembolic strokeSystem Organ Class: 100000004852MedDRA version: 21.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-002176-41-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 654
1. Age = 18 years
2. Written informed consent from the patient or legal representative
3. Recent history of a non-traumatic spontaneous ICH during the 12 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
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 within the last 14 days before enrolment
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method