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Long-term Safety in Atrial Fibrillation Patients

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.
 
ClinicalTrials.gov Identifier: NCT00645853
Recruitment Status : Completed
First Posted : March 28, 2008
Results First Posted : March 6, 2012
Last Update Posted : March 23, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 19, 2008
First Posted Date  ICMJE March 28, 2008
Results First Submitted Date  ICMJE June 30, 2011
Results First Posted Date  ICMJE March 6, 2012
Last Update Posted Date March 23, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period [ Time Frame: 154-711 days on treatment ]
Participants
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2008)
To evaluate safety and tolerability of long-term treatment with AZD0837 compared to Vitamin-K Antagonist (VKA) in Atrial Fibrillation patients with a moderate to high risk of stroke and systemic embolic events.
Change History Complete list of historical versions of study NCT00645853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2008)
To evaluate the PK of AZD0837 and metabolites; To evaluate the effect of AZD0837 on PD markers and coagulation assays in Atrial Fibrillation patients with a moderate to high risk of stroke and systemic embolic events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Safety in Atrial Fibrillation Patients
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Persistent or Permanent Nonvalvular Atrial Fibrillation
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: AZD0837
  • Active Comparator: 2
    Intervention: Drug: VKA INR 2-3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2008)
523
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645853
Other Study ID Numbers  ICMJE D1250C00042
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lars Hvilstedt Rasmussen, MD, PhD, FESC Head of Cardiology at Heart Centre Aalborg Aarhus University Hospital DK 9100 Aalborg Denmark
PRS Account AstraZeneca
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP