Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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
Disqualifiers
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)
Clear indication to anticoagulant or antiplatelet therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Apixaban
DrugPatients who have had an ischemic stroke will receive either an anticoagulant or aspirin according to their randomization arm.
Aspirin
DrugAspirin is used as the standard of care
Treatment groups
1,148 Participants
are divided into 2 treatment groupsGroup A: Therapeutic anticoagulationExperimental treatment 1 intervention
Group B: Aspirin 75-300 mg/dayActive comparator 1 intervention
Trial outcomes
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.
Time frame
During the 12 month follow-upSecondary outcomes
1
Sensitivity (percentage of true positives) in detecting AF
Yield and comparative rates of atrial fibrillation discovered using various tools (Holter-ECG monitoring device, loop recorder (wearing or implantable monitoring device).
Time frame
long term using various tools (3 weeks)2
The Occurrence of: Recurrent fatal or nonfatal ischemic stroke, any stroke, any stroke or TIA or vascular death
Evaluate two commonly used antithrombotic treatment strategies in patients with recent ischemic stroke and at high risk of atrial fibrillation.
Time frame
During the 12 month follow-upSponsors and contacts
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Source ClinicalTrials.gov