Actively Recruiting
Stroke Prevention in Ischemic Stroke With Covert Atrial Fibrillation Using Anticoagulants or Aspirin
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-06-05
1148
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients aged 65 and older who have recently experienced an ischemic stroke with no known cause. These patients might have undetected atrial fibrillation (AF) that was not found during their initial hospital stay. The study aims to evaluate the benefits and risks of using anticoagulant treatment compared to aspirin during the period after hospital discharge when AF detection is ongoing. This research addresses the uncertainty around the best treatment strategy to prevent recurrent strokes in this group. Participants will be randomly assigned to receive either anticoagulant therapy (such as vitamin K antagonists targeting an INR of 2-3 or newer anticoagulants like apixaban, rivaroxaban, or dabigatran) or aspirin at doses from 75 to 300 mg per day. They will be monitored for atrial fibrillation using devices like Holter ECGs, wearable monitors, or implantable loop recorders for up to 12 months. If AF is detected, anticoagulant treatment continues; if not, patients may switch to aspirin after 6 to 12 months. During the study, participants will be regularly evaluated for the occurrence of fatal or nonfatal ischemic strokes or peripheral emboli, with follow-up lasting 12 months. Researchers will assess how well AF detection tools identify true AF cases over three weeks and monitor other stroke-related outcomes. Safety and treatment adherence will be tracked throughout the follow-up period to better understand the impact of these treatment strategies on stroke prevention.
CONDITIONS
Brief Title
Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 65 years or older
- Recent cerebral infarction (less than 15 days) confirmed by MRI or head CT
- No known atrial fibrillation before stroke and none detected during hospital stay
- Suspected atrial fibrillation based on specific clinical or imaging patterns
- Plan to monitor atrial fibrillation using Holter ECG, wearable device, or implantable loop recorder
- Rankin score of 4 or less
- Signed informed consent
- Affiliated to social security
You will not qualify if you...
- Known cause of stroke identified by ASCOD classification
- Symptomatic brain hemorrhage (microbleeds alone do not exclude)
- Uncontrolled hypertension as judged by investigator
- Clear indication for anticoagulant or antiplatelet therapy
- Contraindications to anticoagulant or antiplatelet therapy
- Intercurrent disease interfering with study evaluation or follow-up
- Participation in another interventional clinical trial
- Use of contraception in women of childbearing potential
- Patients under guardianship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive either anticoagulant treatment or aspirin according to their randomization arm to prevent recurrent stroke during the search period for atrial fibrillation.
Regular visits during treatment period (frequency per protocol)
Duration - Up to 12 months post-treatment start
Participants are monitored for the occurrence of ischemic stroke, peripheral emboli, and detection of atrial fibrillation after treatment.
Follow-up visits as scheduled during the 12 month period
Trial Site Locations
Total: 1 location
1
Bichat Hospital
Paris, Paris, France, 75018
Actively Recruiting
Research Team
P
Philippa Lavallée, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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