Stroke prevention in ischemic stroke with covert atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional study examines patients aged 65 and older who recently had an ischemic stroke with no known AF and no AF detected during initial hospitalization but with suspected covert AF. Participants are randomized to receive either apixaban or aspirin as part of the AF-search period, with treatment continuing if AF is confirmed by monitoring or stopped after 6–12 months if AF remains undetected. The trial aims to determine whether early anticoagulation provides superior protection against recurrent strokes compared with aspirin in this specific patient population. Enrollment is limited to patients at Bichat Hospital in Paris under the lead sponsor Assistance Publique - Hôpitaux de Paris. The study integrates prior findings from NAVIGATE-ESUS and RESPECT-ESUS to contextualize long-term therapy decisions. Primary endpoints likely include recurrent ischemic events and safety signals related to anticoagulation in the setting of covert AF detection efforts.

Why it matters

Who can join: the full rules

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

Where it's running

• Bichat Hospital
  Paris, Paris, France Recruiting

Study contacts

• Study coordinator: Philippa Lavallée, PhD
• Email: philippa.lavallee@aphp.fr
• Phone: 1 40 25 87 25

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.