Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)

Completed

Phase 2 Results

Trial Description

The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.

Conditions

Interventions

  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    Intervention Desc: Oral form
  • AZD0837 (Exanta )Drug
    Intervention Desc: ER formulation

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Premature Discontinuation of Study or Study Drug Due to Any Reason 28 week (randomisation visit to last follow up visit in study) according to protocols No
Primary Premature Discontinuation of Study Drug Due to Any Reason 24 weeks (randomisation visit to last treatment visit) No
Primary Premature Discontinuation of Study Due to Any Reason 28 weeks (randomisation visit to last follow up visit) No
Primary Compliance With Study Drug 24 weeks (randomisation visit to last treatment visit) according to protocol No
Primary Compliance With Study Visits/Assessments 28 weeks (randomisation visit to last follow up visit) according to protocol No
Secondary Bleeding Events 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit) Yes
Secondary Change in Creatinine Level 4 weeks according to protocol (randomisation visit to week 4 visit) Yes
Secondary Alanine Aminotransferase (ALAT) 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit) Yes
Secondary Bilirubin 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit) Yes
Secondary Plasma Concentration of AZD0837 (Prodrug) 4 weeks after baseline according to protocol Yes
Secondary Plasma Concentration of AR-H067637XX (Active Metabolite) 4 weeks after baseline according to protocol Yes
Secondary Change in D-Dimer Level 4 weeks according to protocol.(baseline to week 4 visit) Yes
Secondary Activated Partial Thromboplastin Time (APTT) 4 weeks according to protocol.(baseline to week 4 visit) Yes
Secondary Ecarin Clotting Time (ECT) 4 weeks according to protocol.(baseline to week 4 visit) No

Sponsors