Detection of Silent Atrial Fibrillation aFter Ischemic StrOke "SAFFO"


Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

- Age ≥65 years old in the presence of at least one of the following vascular risk factors: hypertension; diabetes; vascular disease (previous myocardial infarction, peripheral arteriopathy).
- Age between 60 and 64 years old in the presence of at least two of the following vascular risk factors: hypertension; diabetes; vascular disease (previous myocardial infarction, peripheral arteriopathy); smoking.
- Recent (30-60 days after symptom onset) diagnosis of first-ever ischemic stroke. Ischemic stroke is defined as an event characterized by the sudden onset of acute focal neurological symptoms, MR or CT findings consistent with ischemic stroke, and no evidence of other neurological disorders clinically or radiographically to explain. Patients with reversible neurological deficit within 24 hours (clinical TIA), but with a cerebral injury of ischemic origin visible on neuroimages and corresponding to patient symptoms, have to be classified as having an ischemic stroke and considered for the study.
- Diagnosis of atherothrombotic and lacunar etiology, defined according to the TOAST classification criteria and standard diagnostic protocols that have to be fulfilled before randomization (medical history; risk factors; symptoms; cerebral MR and/or CT; 12-lead ECG and/or Holter ECG and/or other standard heart rhythm monitoring procedure; transthoracic and/or transoesophageal echocardiogram; intra- and extracranial vessel ultrasonography and/or CT-Angiography and/or MR-Angiography, also in order to rule out non-atherosclerotic vasculopathies; thrombophilic/hematologic screening if hypercoagulability states or other hematologic disorders are suspected).
- Neurological severity in terms of functional dependency defined as mRS (modified Rankin Scale) score ≤3.
- Written informed consent.

Exclusion Criteria

- TIA without evidence of cerebral infarction on neuroimaging corresponding to patient symptoms.
- Diagnosis of cardioembolic stroke based on medical history and cerebral/cardiological/vascular diagnostic evaluation (e.g., evidence of a high-risk emboligenic source from the heart or aortic arch such as: left ventricle or atrium thrombus or "smoke", emboligenic valvular lesions, or emboligenic tumor, patent foramen ovale [PFO] associated with a possible venous thromboembolic source and hence eligible for oral anticoagulant [OAC] therapy, aortic arch plaques having >3 mm thickness or containing mobile components, or any other high-risk embolic lesion).
- Diagnosis of ischemic stroke of different etiopathogenesis, for example due to non-atherosclerotic vasculopathies, hypercoagulability states (diagnosed by a thrombophilic screening) or other hematologic disorders; or diagnosis of cryptogenic stroke.
- Previous documented history of atrial fibrillation (AF) or atrial flutter (AFL)
- History of untreated hyperthyroidism
- History of myocardial infarction <1 month before the study screening visit
- Valvular disease requiring immediate surgical intervention
- Recent (<6 months before the study screening visit) cardiac surgery
- Other conditions associated with an increased risk of AF: sick sinus syndrome, recent (<14 days before the study Screening visit) surgery; current infections
- Permanent indication for anticoagulation
- Contraindications to OAC therapy
- Stroke associated with severe functional disability defined as mRS>3
- Hear failure associated with severe ventricular dysfunction and ejection fraction ≤40%
- Indication for pacemaker or defibrillator implant
- Any condition that, in the opinion of the investigator, could make non feasible or hazardous patient's participation in the study or any condition that could compromise the completion of patient's participation in terms of follow-up visits (for example, diseases associated with a poor prognosis and life expectancy <1 year).
- Severe renal failure or liver disease
- Participation in any other clinical trial that can interfere with the objectives of the study
- Poor patient's compliance that could compromise his/her correct participation in the study
- Patient's refusal to give his/her informed consent for the participation in the study.