A randomized, register based study to Compare Extended Versus Standard ECG Monitoring in Patients with Ischemic Stroke or TIA to detect atrial fibrillation and reduce the risk of stroke - AF SPICE

The purpose of the trial is to study the prognostic impact of ECG investigation after stroke or Transient Ischemic Attack (TIA).The aim is to investigate if extended ECG screening after stroke or TIA as compared to standard ECG screening for atrial fibrillation reduces the occurrence of the primary composite endpoint of stroke, death and intracranial bleeding.P: Patients aged ≥70-years and admitted for ischemic stroke/TIA in Swedish stroke units.

I: Extended long-term ECG-recording of 14 + 14 days duration using patch ECG, read in a core facility.

Oral anticoagulation treatment will be suggested to all cases detected with atrial fibrillation in intervention and control arm unless contraindicated.C: Standard ECG recording of 48 hO: Primary outcome is a composite of stroke, all-cause mortality and intracerebral bleeding.

Secondary and exploratory oucomes include the individual components of the primary endpoint, intracranial bleedning, myocardial infarction, major bleeding and pacemaker implantation.

Endpoint and majority of baseline data will be collected from Swedish health care registers, mainly Riksstroke but also inpatient, drug prescription and cause of death register. Sample size is estimated at 2700.

Pilot study commenced ni 2022, main trial is planned to recruit 2023-2026 and follow-up 2027-2028.Given a positive result, the study will give evidence to an investigation and treatment that will improve prognosis in a large group of patients with very poor prognosis.