Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation Ranolazine Dronedarone Dual Chamber Pacemakers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 134
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment. AFB is defined as the total time a participant is in atrial tachycardia/atrial fibrillation (AT/AF) expressed as a percentage of total recording time.

Detailed description:

Arms:
arm 1: Ranolazine placebo plus dronedarone placebo for 12 weeks. arm 2: Ranolazine 750 mg plus dronedarone placebo for 12 weeks. arm 3: Ranolazine placebo plus dronedarone 225 mg for 12 weeks. arm 4: Ranolazine 750 mg plus dronedarone 225 mg for 12 weeks. arm 5: Ranolazine 750 mg plus dronedarone 150 mg for 12 weeks.

Interventions: intervention 1: Ranolazine intervention 2: Dronedarone intervention 3: Ranolazine placebo intervention 4: Dronedarone placebo
Intervention descriptions: intervention 1: Tablets administered orally twice daily. intervention 2: Capsule administered orally twice daily intervention 3: Tablets administered orally twice daily. intervention 4: Capsules administered orally twice daily

Protocol document: