Long-term Safety in Atrial Fibrillation Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00645853
First received: March 19, 2008
Last updated: March 20, 2012
Last verified: March 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    Participants


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

  • Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline [ Time Frame: From baseline to Follow up ] [ Designated as safety issue: Yes ]
  • Creatinine: Absolute Change From Baseline, at End of Treatment [ Time Frame: Baseline and End of treatment ] [ Designated as safety issue: Yes ]
  • D-dimer:Median and Quartile Range at End of Treatment [ Time Frame: End of treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Median Full range, Seconds

  • Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment [ Time Frame: Baseline and End of Treatment ] [ Designated as safety issue: Yes ]
  • AZD0837: Plasma Concentration of AZD0837 at End of Treatment [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment [ Time Frame: 154-711 days on treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00645853     History of Changes
Other Study ID Numbers: D1250C00042
Study First Received: March 19, 2008
Results First Received: June 30, 2011
Last Updated: March 20, 2012
Health Authority: Denmark: Danish Medicines Agency
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Sweden: Medical Products Agency
Austria: Agency for Health and Food Safety
Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014