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Long-term Safety in Atrial Fibrillation Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00645853
First Posted: March 28, 2008
Last Update Posted: March 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and systemic embolic events (moderate to high risk patients).

Condition Intervention Phase
Persistent or Permanent Nonvalvular Atrial Fibrillation Drug: AZD0837 Drug: VKA INR 2-3 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Long-term Treatment With the Oral Direct Thrombin Inhibitor AZD0837, Compared to Vitamin-K Antagonists, as Stroke Prevention in Patients With Non-valvular Atrial Fibrillation and One or More Risk Factors for Stroke and Systemic Embolic Events. A 5-year Follow-up Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period [ Time Frame: 154-711 days on treatment ]
    Participants


Secondary Outcome Measures:
  • Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline [ Time Frame: From baseline to Follow up ]
    ULN=Upper limit of Normal

  • Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline [ Time Frame: From baseline to Follow up ]
  • Creatinine: Absolute Change From Baseline, at End of Treatment [ Time Frame: Baseline and End of treatment ]
  • D-dimer:Median and Quartile Range at End of Treatment [ Time Frame: End of treatment ]
    Median (Lower Quartile-Upper Quartile ), ng/mL

  • Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment [ Time Frame: Baseline and End of treatment ]
    Median Full range, Seconds

  • Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment [ Time Frame: Baseline and End of Treatment ]
  • AZD0837: Plasma Concentration of AZD0837 at End of Treatment [ Time Frame: End of treatment ]
  • AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment [ Time Frame: 154-711 days on treatment ]

Enrollment: 523
Study Start Date: October 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD0837
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
Active Comparator: 2 Drug: VKA INR 2-3
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
Other Name: warfarin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with paroxysmal, persistent or permanent Non Valvular Atrial Fibrillation with one or more additional risk factors for stroke and systemic embolic event
  • completing treatment with study drug in D1250C00008.

Exclusion Criteria:

  • Atrial Fibrillation secondary to reversible disorders, eg hyperthyroidism
  • Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than Atrial Fibrillation requiring chronic anticoagulation treatment
  • Myocardial infarction, heart surgery or percutaneous coronary intervention (PCI) within the previous three months prior to inclusion; Stroke and/or systemic embolism within the previous 30 days prior to inclusion
  • Conditions associated with increased risk of major bleeding.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645853


Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Lars Hvilstedt Rasmussen, MD, PhD, FESC Head of Cardiology at Heart Centre Aalborg Aarhus University Hospital DK 9100 Aalborg Denmark
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00645853     History of Changes
Other Study ID Numbers: D1250C00042
First Submitted: March 19, 2008
First Posted: March 28, 2008
Results First Submitted: June 30, 2011
Results First Posted: March 6, 2012
Last Update Posted: March 23, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamin K
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs