Apixaban compared with parenteral heparin and/or vitamin K antagonist in patients with nonvalvular atrial fibrillation undergoing cardioversion: Rationale and design of the EMANATE trial
| Autor: | William Petkun, Charles V. Pollack, Jonas Oldgren, Judith Spahr, Paul Sanders, Paulus Kirchhof, Andrei Breazna, Michael D. Ezekowitz, Jonathan L. Halperin, Nilo B. Cater |
|---|---|
| Jazyk: | angličtina |
| Předmět: |
medicine.drug_class
Pyridones medicine.medical_treatment Electric Countershock Hemorrhage 030204 cardiovascular system & hematology Cardioversion law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Atrial Fibrillation medicine Humans Cardiac and Cardiovascular Systems 030212 general & internal medicine Stroke Kardiologi business.industry Heparin Anticoagulant Warfarin Anticoagulants Atrial fibrillation Vitamin K antagonist medicine.disease Anesthesia Pyrazoles Apixaban Drug Therapy Combination business Cardiology and Cardiovascular Medicine medicine.drug Factor Xa Inhibitors |
| Zdroj: | American Heart Journal. :59-68 |
| ISSN: | 0002-8703 |
| DOI: | 10.1016/j.ahj.2016.06.008 |
| Popis: | BackgroundStroke prevention in anticoagulation-naïve patients with atrial fibrillation undergoing cardioversion has not been systematically studied.ObjectiveTo determine outcomes in anticoagulation-naïve patients (defined as those receiving an anticoagulant for 80 years, weight 1.5 mg/dL. If cardioversion is immediate, a single starting dose of 10 mg (or 5 mg if the dose is down-titrated) of apixaban is administered. Cardioversion may be attempted up to 90 days after randomization. Patients are followed up for 30 days after cardioversion or 90 days postrandomization if cardioversion is not performed within that timeframe. Outcomes are stroke, systemic embolization, major bleeds, clinically relevant nonmajor bleeding, and death, all adjudication-blinded.StatisticsThe warfarin-naive cohort from the ARISTOTLE study was considered the closest data set to the patients being recruited into this study. The predicted incidence of stroke, systemic embolism, and major bleeding within 30 days after randomization was approximately 0.75%. To adequately power for a noninferiority trial, approximately 48,000 participants would be needed, a number in excess of feasibility. The figure of 1,500 patients was considered clinically meaningful and achievable.Clinical contextThis first prospective cardioversion study of a novel anticoagulant in anticoagulation-naïve patients should influence clinical practice. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|