Projekt

ARTESIA

Abgeschlossen - Rekrutierung – beendet · 2016 bis 2026

Art
Klinische Forschung
Reichweite
Multizentrisch, KSSG als teilnehmendes Zentrum
Bereiche
Status
Abgeschlossen - Rekrutierung – beendet
Start
2016
Ende
2026
Finanzierungsart
Industrie
Studiendesign
Prospective, randomized, parallel group, double-blind trial
Schlagwörter (Tags)
APIXABAN FOR THE REDUCTION OF THROMBO-EMBOLISM
Projektpartner
Funded by: Bristol-Myers Squibb, Pfizer, Medtronic and the Canadian Institutes of Health Research
Kurzbeschreibung/Zielsetzung

Study Hypothesis:
In patients with evidence of device-detected sub-clinical atrial fibrillation (SCAF) and additional risk factors for stroke, treatment with apixaban compared with aspirin will reduce the risk of the composite of stroke and systemic embolism.

Study Objectives
To determine if the use of apixaban in patients with SCAF will reduce the incidence of stroke and systemic embolism compared to aspirin.

Primary Outcomes:
Efficacy: Composite of stroke (including transient ischemic attack (TIA) with evidence of cerebral infarction on diffusion-weighted MRI) and systemic embolism
Safety: Major bleeding as defined by the ISTH criteria

The study will enroll patients with a CHA2DS2-VASc score of at least 4 and who have an implanted pacemaker or defibrillator (with or without resynchronization) or an insertable cardiac monitor (ICM) which shows at least 6 minutes, but not more than 24 hours of sub-clinical atrial fibrillation.