EUCTR2018-002176-41-ES
Active, not recruiting
Phase 1
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF) - PRESTIGE-AF
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
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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)
Outcomes
Primary Outcomes
Not specified
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