drugset / Trial / NCT01817439

Safety and Efficacy of Oral Versus Intravenous Amiodarone in the Treatment of AF

NCT01817439

Phase 3 Unknown 104 enrolled Western Galilee Hospital-Nahariya
RandomizedParallel-groupOpen-labelTreatment

Summary

Atrial fibrillation (AF) remains a significant contributor to cardiovascular morbidity. Amiodarone is a potent antiarrhythmic drug; however, patients receiving IV amiodarone are at high risk for phlebitis. Phlebitis may lead to infection, additional medical intervention, delay in treatment, and prolonged hospitalization. Therefore, examining new therapy approach, aimed to reduce the incidence of phlebitis is a valuable clinical and research goal. Aim: To evaluate the safety and efficacy of oral versus intravenous (IV) Amiodarone in the treatment of AF of recent onset (duration \< 48 h).

Timeline

Start
2013-05
Primary completion
2015-05
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Amiodarone Small molecule 400 mg Oral
Subject Amiodarone Small molecule 900 mg Oral

Indications