RecruitingPhase 4NCT06486792

Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

1,148 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Stroke Ischemic Stroke Cerebral Infarction

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 patients are typically monitored for AF using devices like Holter monitors or implantable loop recorders. Treatment options during this period include anticoagulants or aspirin. Anticoagulants are more effective in preventing recurrent strokes if AF is present, offering an 80% risk reduction compared to aspirin's 20%. If AF is detected, anticoagulant treatment continues; if not, patients may switch to aspirin after 6-12 months. Despite the clinical rationale for using anticoagulants during this search period, their benefit-risk ratio compared to aspirin has not been fully evaluated.

Eligibility

Min Age: 65 Years

Inclusion Criteria14

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 Criteria8

Patients with a known cause of stroke, using ASCOD classification A1, C1, S1, O1, D1
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