SHORT RUN AF. Rivaroxaban versus standard of care for patients with excessive atrial ectopy or short atrial runs and high embolism risk

Patients with excessive supraventricular ectopies or short atrial runs (ESVEA) defined as ≥ 1% premature atrial contractions (PAC) /24 hours or any atrial runs ≥ 20 PACs (but shorter than 30 seconds) on a 24-hour Holter ECG monitoring and CHA2DS2VASC score ≥ 3. Patients with any atrial runs ≥ 20 PACs but shorter than 30 seconds on a 15-21 days Holter ECG monitoring and CHA2DS2VASC score ≥ 3 may also be included in the Short-Run trial.

The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis., The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).

Efficacy-related endpoints: o A composite of ischemic stroke, peripheral embolism or major bleeding (net clinical benefit); a composite of death from cardiovascular causes, stroke, systemic embolism, myocardial infarction (major cardiovascular events); death from any cause; cognitive decline as assessed by the MMS (26). o Individual components of composite primary and secondary efficacy endpoints, Exploratory endpoints: o Incidence of documented atrial fibrillation diagnosed from patient symptoms or systematic 24 hours ECG Holter performed at 1- and 2-year follow-up. o Incidence of asymptomatic MRI-detected cerebral damage including silent cerebral ischemia and microbleeds at 2-year follow up., Safety-related endpoints: o Life-threatening or fatal bleeding events, clinically relevant non-major bleeding intracranial hemorrhage and minor bleeding events. Bleeding severity will be assessed according to ISTH classification.

No related papers found yet.

France