Phase 2
N=949
Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation
Nonvalvular Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00684307 ↗Enrolled (actual)
949
Serious AEs
14.7%
Results posted
Sep 2011
Primary outcome: Primary: Bleeding Events — 18; 8; 22; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD0837 (Drug); Vitamin-K antagonist at INR 2-3 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bleeding Events |
18; 8; 22; 17; 46 | — |
| PRIMARY Creatinine |
5.95; 4.81; 7.56; 9.22; 0.43 | — |
| PRIMARY Alanine Aminotransferase (ALAT) |
6; 1; 5; 2; 5 | — |
| PRIMARY Bilirubin |
1; 0; 0; 3; 2 | — |
| SECONDARY D-Dimer |
-46.4; -76.9; -45.2; -68.0; -50.3 | — |
| SECONDARY Activated Partial Thromboplastin Time (APTT) |
8.2; 12.3; 17.4; 16.4 | — |
| SECONDARY Ecarin Clotting Time (ECT) |
33.5; 53.0; 64.0; 73.5 | — |
| SECONDARY Plasma Concentration of AZD0837 (Prodrug) |
199.8; 617.5; 564.5; 1143.5 | — |
| SECONDARY Plasma Concentration of AR-H067637XX (Active Metabolite) |
223.8; 373.6; 454.8; 600.8 | — |
| SECONDARY Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT |
39.7; 42.4; 36.3; 35.6 | — |
| SECONDARY Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC |
39.2; 39.3; 37.7; 40 | — |
| SECONDARY Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC |
40.9; 41.1; 43.4; 39.6 | — |
Summary
The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.
Eligibility Criteria
Inclusion Criteria
- Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at least one week.
- Previous cerebral ischemic attack (stroke or TIA, >30 days prior to randomization)
- Previous systemic embolism.
- Symptomatic congestive heart failure (CHF)
- Impaired left ventricular systolic function
- Diabetes mellitus
- Hypertension requiring anti-hypertensive treatment.
Exclusion Criteria
- AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism
- Known contraindication to VKA treatment
- Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment
- Conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization
Data sourced from ClinicalTrials.gov (NCT00684307). 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.