Status:
NOT_YET_RECRUITING
Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Stroke
Ischemic Stroke
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
Patients who have recently had an ischemic stroke with no clear cause might have undetected atrial fibrillation (AF) that isn't caught during their initial hospital stay. After discharge, these patien...
Detailed Description
Patients with recent ischemic stroke with an unknown cause may have a clinical, radiological and echocardiographic pattern of covert atrial fibrillation which is yet undetected by history, ECG monitor...
Eligibility Criteria
Inclusion
- Included patients must fulfill the following 4 criteria:
- patient aged ≥65 years with:
- recent (\<15 days) cerebral infarction
- with cerebral ischemia proven on MRI or head-CT
- with no known atrial fibrillation before stroke and no atrial fibrillation detected during hospital stay (monitoring or telemetry) and no mural thrombus.
- but with suspected atrial fibrillation:
- multiple territorial (i.e., in the territory of a cerebral artery or one of its branches) cerebral infarctions in several arterial territories involving both hemispheres, or in the same hemisphere, or in both anterior and posterior circulation, symptomatic or not
- or a single cerebral infarction and systemic emboli (e.g., renal, splenic, hepatic or mesenteric infarction, peripheral emboli in arm or leg), symptomatic or not
- or any ischemic stroke with dilation of atrium (\>34 mL/m²) or left atrial spontaneous echocardiographic contrast or LAA velocities \< 40 cm/sec or pro BNP \> 400 pg/mL or left ventricular ejection fraction (LVEF) \< 40% or supraventricular extrasystole ≥ 400/24 h or longest "atrial run" ≥ 20 beats on telemetry
- or age ≥80 year-old and a single infarction
- and a plan to detect atrial fibrillation with, long term Holter ECG, wearing device or implantable loop recorder
- with a Rankin score equal or less than 4
- patient has signed an informed consent
- Patient is affiliated to a social security.
Exclusion
- Patients with a known cause of stroke, using ASCOD classification A1, C1, S1, O1, D1
- Symptomatic brain hemorrhage (the mere presence of microbleeds on gradient echo imaging is not an exclusion criteria)
- Uncontrolled hypertension (following the judgment of the investigator)
- Clear indication to anticoagulant or antiplatelet therapy
- Contra-indication to anticoagulant or antiplatelet therapy
- Intercurrent disease that may interfere with evaluation of the primary end-point or that may prevent follow-up study visits
- Participation in another interventional clinical trial.
- Under contraception in case of childbearing potential
- Patient under guardianship or curatorship
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
1148 Patients enrolled
Trial Details
Trial ID
NCT06486792
Start Date
September 1 2024
End Date
March 1 2028
Last Update
July 5 2024
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