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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00623779
First received: February 15, 2008
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Persistent or Permanent Non-valvular Atrial Fibrillation
Drug: AZD0837
Drug: Aspirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Controlled, Randomized, Parallel , Multi-centre Feasibility Study of the Oral Direct Thrombin Inhibitor, AZD0837, Given as ER Formulation, in the Prevention of Stroke and Systolic Embolic Events in Patients With Atrial Fibrillation, Who Are Appropriate for But Unable/Unwilling to Take VKA Therapy

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Premature Discontinuation of Study or Study Drug Due to Any Reason [ Time Frame: 28 week (randomisation visit to last follow up visit in study) according to protocols ] [ Designated as safety issue: No ]
    The premature discontinuation of study or study drug due to any reason

  • Premature Discontinuation of Study Drug Due to Any Reason [ Time Frame: 24 weeks (randomisation visit to last treatment visit) ] [ Designated as safety issue: No ]
    The premature discontinuation of study drug due to any reason

  • Premature Discontinuation of Study Due to Any Reason [ Time Frame: 28 weeks (randomisation visit to last follow up visit) ] [ Designated as safety issue: No ]
    /The premature discontinuation of study due to any reason

  • Compliance With Study Drug [ Time Frame: 24 weeks (randomisation visit to last treatment visit) according to protocol ] [ Designated as safety issue: No ]
    [(number of doses dispensed-number of doses returned)/number of days between visits]*100

  • Compliance With Study Visits/Assessments [ Time Frame: 28 weeks (randomisation visit to last follow up visit) according to protocol ] [ Designated as safety issue: No ]
    (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:
  • Bleeding Events [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once

  • Change in Creatinine Level [ Time Frame: 4 weeks according to protocol (randomisation visit to week 4 visit) ] [ Designated as safety issue: Yes ]
    Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)

  • Alanine Aminotransferase (ALAT) [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal.

  • Bilirubin [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    Number of patients while on study drug with Bilirubin>=2 times upper limit of normal.

  • Plasma Concentration of AZD0837 (Prodrug) [ Time Frame: 4 weeks after baseline according to protocol ] [ Designated as safety issue: Yes ]
    Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit

  • Plasma Concentration of AR-H067637XX (Active Metabolite) [ Time Frame: 4 weeks after baseline according to protocol ] [ Designated as safety issue: Yes ]
    Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit 

  • Change in D-Dimer Level [ Time Frame: 4 weeks according to protocol.(baseline to week 4 visit) ] [ Designated as safety issue: Yes ]
    Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)

  • Activated Partial Thromboplastin Time (APTT) [ Time Frame: 4 weeks according to protocol.(baseline to week 4 visit) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 4 weeks according to protocol.(baseline to week 4 visit) ] [ Designated as safety issue: No ]
    Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)


Enrollment: 128
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD0837
    ER formulation
    Drug: Aspirin
    Oral form
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623779

  Show 39 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Gregory Y Lip, MD Birmingham City Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00623779     History of Changes
Other Study ID Numbers: D1250C00051
Study First Received: February 15, 2008
Results First Received: June 30, 2011
Last Updated: March 20, 2012
Health Authority: Denmark: Danish Medicines Agency
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Aspirin
Antithrombins
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants

ClinicalTrials.gov processed this record on August 21, 2014