Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation

NCT06486792 | Recruiting Phase 4

• 1 other identifier: APHP230839
• Study Type: interventional
• Target: 1,148
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stroke; Ischemic Stroke; Cerebral Infarction; Atrial Fibrillation

Keywords

Stroke; Ischemic Stroke; Cerebral infarction; Atrial Fibrillation; Anticoagulant; Aspirin; Prevention stroke; AVK; Apixaban; rivaroxaban; dabigatran; ECG

Outcome Measures

Primary Outcomes (1)

• Occurrence of fatal or nonfatal ischemic stroke, or peripheral emboli (even if asymptomatic) [peripheral emboli: emboli in arm or leg, new renal, splenic, hepatic, mesenteric infarction]

  Evaluate two commonly used antithrombotic treatment strategies in patients with recent ischemic stroke and at high risk of atrial fibrillation.

  During the 12 month follow-up

Secondary Outcomes (2)

• Sensitivity (percentage of true positives) in detecting AF

  long term using various tools (3 weeks)

• The Occurrence of: Recurrent fatal or nonfatal ischemic stroke, any stroke, any stroke or TIA or vascular death

  During the 12 month follow-up

Study Arms (2)

Therapeutic anticoagulation

EXPERIMENTAL

Choice of the investigator, VKA with target INR 2-3, or apixaban, rivaroxaban or dabigatran)

Drug: Apixaban

Aspirin 75-300 mg/day

ACTIVE COMPARATOR

Aspirin is the standard of care treatment.

Drug: Aspirin

Interventions

Apixaban DRUG

Patients who have had an ischemic stroke will receive either an anticoagulant or aspirin according to their randomization arm.

Also known as: AVK, rivaroxaban, dabigatran

Therapeutic anticoagulation

Aspirin DRUG

Aspirin is used as the standard of care

Aspirin 75-300 mg/day

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat Hospital

Paris, Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Cerebral Infarction; Atrial Fibrillation

Interventions

apixaban; Rivaroxaban; Dabigatran; Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arrhythmias, Cardiac; Heart Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Philippa Lavallée, PhD

CONTACT

1 40 25 87 25; philippa.lavallee@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be evaluated blindly by the members of the critical event committee. They will receive medical files without the patient's name, surname, phone number, or address.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial, open-labelled, of two standard of care therapeutic strategies: therapeutic anticoagulation (choice of the investigator, VKA with target INR 2-3, or apixaban, rivaroxaban or dabigatran) vs aspirin 75-300 mg/day

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 5, 2024
• Study Start: June 18, 2025
• Primary Completion (Estimated): December 18, 2028
• Study Completion (Estimated): December 18, 2028
• Last Updated: June 5, 2026

Record last verified: 2025-07

Locations

FR (1)