EUCTR2018-002176-41-DE
Active, not recruiting
Phase 1
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF)
ConditionsIschaemic 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ischaemic stroke prevention in patients with atrial fibrillation and previous intracerebral haemorrhage
- Sponsor
- Imperial College of Science Technology and Medicine
- Enrollment
- 654
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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 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
Outcomes
Primary Outcomes
Not specified
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