Conditions: Nonvalvular Atrial Fibrillation
Keywords: Anticoagulant Treatment Risk Factors For Stroke
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1084
Healthy volunteers: no

Brief summary:
The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.

Detailed description:

Arms:
arm 1: AZD0837 450 mg arm 2: AZD0837 200 mg arm 3: AZD0837 300 mg arm 4: AZD0837 150 mg arm 5: Vitamin-K antagonist at INR 2-3

Interventions: intervention 1: AZD0837 intervention 2: Vitamin-K antagonist at INR 2-3 intervention 3: AZD0837
Intervention descriptions: intervention 1: ER tablet, PO, once daily for a period of 3-9 months. intervention 2: Tablet, PO for a period of 3-9 months. intervention 3: ER tablet, PO, twice daily for a period of 3-9 months

Protocol document: