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

Phase 2

Completed

Conditions: Persistent or Permanent Non-valvular Atrial Fibrillation

Registration Number: NCT00623779

Lead Sponsor: AstraZeneca

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

Inclusion Criteria

Either one of the following risk factors is sufficient for inclusion (high risk patient)
Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), >30 days prior to randomization)
Previous systemic embolism or at least one of the following risk factors are needed for inclusion: Age ≥75 years
Symptomatic congestive heart failure
Impaired left ventricular systolic function
Diabetes mellitus; Hypertension requiring anti-hypertensive treatment
In addition to AF the patient must be appropriate for but unable or unwilling to take VKA therapy

Exclusion Criteria

Presence of a clinically significant valvular heart disease;; Stroke or TIA and/or systemic embolism within the previous 30 days prior to randomization
Conditions associated with increased risk of major bleeding

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	The premature discontinuation of study or study drug due to any reason
Premature Discontinuation of Study Drug Due to Any Reason	24 weeks (randomisation visit to last treatment visit)	The premature discontinuation of study drug due to any reason
Premature Discontinuation of Study Due to Any Reason	28 weeks (randomisation visit to last follow up visit)	\\|The premature discontinuation of study due to any reason
Compliance With Study Drug	24 weeks (randomisation visit to last treatment visit) according to protocol	\[(number of doses dispensed-number of doses returned)/number of days between visits\]\*100
Compliance With Study Visits/Assessments	28 weeks (randomisation visit to last follow up visit) according to protocol	(number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)\*100

Secondary Outcome Measures

Name	Time	Method
Change in Creatinine Level	4 weeks according to protocol (randomisation visit to week 4 visit)	Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Activated Partial Thromboplastin Time (APTT)	4 weeks according to protocol.(baseline to week 4 visit)	Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Ecarin Clotting Time (ECT)	4 weeks according to protocol.(baseline to week 4 visit)	Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
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)	Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once
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)	Number of patients while on study drug with Alanine aminotransferase (ALAT)\>=3 times upper limit of normal.
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)	Number of patients while on study drug with Bilirubin\>=2 times upper limit of normal.
Plasma Concentration of AZD0837 (Prodrug)	4 weeks after baseline according to protocol	Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit
Plasma Concentration of AR-H067637XX (Active Metabolite)	4 weeks after baseline according to protocol	Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit
Change in D-Dimer Level	4 weeks according to protocol.(baseline to week 4 visit)	Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)