Informations générales (source: ClinicalTrials.gov)

NCT06486792 En recrutement IDF
Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
Interventional
  • Fibrillation auriculaire
  • Infarctus cérébral
  • Accident vasculaire cérébral
Phase 4
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2025
décembre 2028
10 juin 2026
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.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FOCH BERTRAND LAPERGUE En recrutement IDF 22/06/2026 07:26:08  Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Bichat Philippa LAVALLEE Contact (sur clinicalTrials)

Critères

Tous


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