Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how to prevent strokes in patients who have recently experienced an ischemic stroke (a type of stroke caused by a blockage) and may have undetected atrial fibrillation (AF), a heart condition that can lead to blood clots and more strokes. Researchers want to find out if using blood-thinning medications (anticoagulants) during the time when patients are being monitored for AF is more effective than using aspirin, especially since anticoagulants can significantly reduce the risk of having another stroke if AF is found.

To participate in this trial, patients must be at least 65 years old and have had a stroke less than 15 days ago, with no known AF before the stroke and no AF detected during their hospital stay. They should also have certain signs indicating that they might have AF, such as multiple strokes in different areas of the brain or specific heart-related findings. Participants will be monitored for AF using devices like Holter monitors or implantable loop recorders, and their experience will help doctors better understand the best treatment options for preventing future strokes in similar patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Included patients must fulfill the following 4 criteria:
• 1. patient aged ≥65 years with:
• • 1. recent (\<15 days) cerebral infarction
• • 2. with cerebral ischemia proven on MRI or head-CT
• • 2. with no known atrial fibrillation before stroke and no atrial fibrillation detected during hospital stay (monitoring or telemetry) and no mural thrombus.
• 3. but with suspected atrial fibrillation:
• • 1. 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
• • 2. 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
• • 3. 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
• • 4. or age ≥80 year-old and a single infarction
• • 4. and a plan to detect atrial fibrillation with, long term Holter ECG, wearing device or implantable loop recorder
• • 5. with a Rankin score equal or less than 4
• • 6. patient has signed an informed consent
• • 7. Patient is affiliated to a social security.
• Exclusion Criteria:
• • 1. Patients with a known cause of stroke, using ASCOD classification A1, C1, S1, O1, D1
• • 2. Symptomatic brain hemorrhage (the mere presence of microbleeds on gradient echo imaging is not an exclusion criteria)
• • 3. Uncontrolled hypertension (following the judgment of the investigator)
• • 4. Clear indication to anticoagulant or antiplatelet therapy
• • 5. Contra-indication to anticoagulant or antiplatelet therapy
• • 6. Intercurrent disease that may interfere with evaluation of the primary end-point or that may prevent follow-up study visits
• • 7. Participation in another interventional clinical trial.
• • 8. Under contraception in case of childbearing potential
• • 9. Patient under guardianship or curatorship