Tests apixaban or aspirin after stroke with possible hidden atrial fibrillation
Tests apixaban against aspirin to prevent repeat strokes in older adults.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Registry title
- Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 1,148 people, planned
- Started
- 18 Jun 2025
- Expected to end
- 18 Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Apixaban
- Aspirin
- Record updated
- 5 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 65 or older who had an ischemic stroke in the last 15 days with no known cause but a suspected hidden atrial fibrillation, and who will be monitored for it.
- Age
- 65 years or older
- Sex
- All sexes can join
- Disease stage
- Recent (less than 15 days) cerebral infarction proven on MRI or head CT, no known atrial fibrillation before or during the hospital stay, but atrial fibrillation is suspected (for example infarctions in several arterial territories, a single infarction with emboli elsewhere in the body, signs of heart abnormality, or age 80 or older with a single infarction). Rankin score of 4 or less.
- Earlier treatment
- No clear need for anticoagulant or antiplatelet treatment before. A plan to look for atrial fibrillation with a long-term Holter ECG, a wearable device or an implantable loop recorder.
- Biomarker or test result
- Suspected atrial fibrillation based on findings such as atrium dilation (>34 mL/m²), pro BNP > 400 pg/mL, LVEF < 40%, or supraventricular extrasystole ≥ 400/24 h.
Main reasons for not taking part
- Known cause of stroke (ASCOD classification A1, C1, S1, O1, D1)
- Symptomatic brain hemorrhage
- Uncontrolled hypertension
- Clear indication or contraindication to anticoagulant or antiplatelet therapy
- Taking part in another interventional clinical trial
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Clear indication to anticoagulant or antiplatelet therapy
- Contra-indication to anticoagulant or antiplatelet therapy
- 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)
- 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
Where in France
- Bichat HospitalParis, FranceContact: Philippa LAVALLEETaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Therapeutic anticoagulationTreatment being tested
Choice of the investigator, VKA with target INR 2-3, or apixaban, rivaroxaban or dabigatran)
Treatment: Apixaban
- Aspirin 75-300 mg/dayExisting treatment, for comparison
Aspirin is the standard of care treatment.
Treatment: Aspirin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
- Plain-language title
- Tests apixaban or aspirin after stroke with possible hidden atrial fibrillationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 June 2026