Phase 2
N=523
Long-term Safety in Atrial Fibrillation Patients
Persistent or Permanent Nonvalvular Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00645853 ↗Enrolled (actual)
523
Serious AEs
25.6%
Results posted
Mar 2012
Primary outcome: Primary: Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period — 55; 56 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD0837 (Drug); VKA INR 2-3 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period |
55; 56 | — |
| SECONDARY Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline |
9; 6 | — |
| SECONDARY Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline |
3; 3 | — |
| SECONDARY Creatinine: Absolute Change From Baseline, at End of Treatment |
3.70; -1.17 | — |
| SECONDARY D-dimer:Median and Quartile Range at End of Treatment |
68.9; 54.9 | — |
| SECONDARY Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment |
12.9 | — |
| SECONDARY Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment |
49.0 | — |
| SECONDARY AZD0837: Plasma Concentration of AZD0837 at End of Treatment |
675 | — |
| SECONDARY AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment |
341 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00645853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.