Phase 2
N=128
Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)
Persistent or Permanent Non-valvular Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00623779 ↗Enrolled (actual)
128
Serious AEs
5.5%
Results posted
Jul 2011
Primary outcome: Primary: Premature Discontinuation of Study or Study Drug Due to Any Reason — 4; 6; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD0837 (Drug); Aspirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Premature Discontinuation of Study or Study Drug Due to Any Reason |
4; 6; 3 | — |
| PRIMARY Premature Discontinuation of Study Drug Due to Any Reason |
3; 3; 1 | — |
| PRIMARY Premature Discontinuation of Study Due to Any Reason |
4; 4; 2 | — |
| PRIMARY Compliance With Study Drug |
96.95; 99.82 | — |
| PRIMARY Compliance With Study Visits/Assessments |
93.3; 95.6; 97.5 | — |
| SECONDARY Bleeding Events |
0; 5; 2 | — |
| SECONDARY Change in Creatinine Level |
6.2; 3.6; 2.6 | — |
| SECONDARY Alanine Aminotransferase (ALAT) |
0; 0; 1 | — |
| SECONDARY Bilirubin |
1; 0; 0 | — |
| SECONDARY Plasma Concentration of AZD0837 (Prodrug) |
596.0; 636.0 | — |
| SECONDARY Plasma Concentration of AR-H067637XX (Active Metabolite) |
258.5; 368.5 | — |
| SECONDARY Change in D-Dimer Level |
-33.484; -41.445; 4.853 | — |
| SECONDARY Activated Partial Thromboplastin Time (APTT) |
31.74; 51.51 | — |
| SECONDARY Ecarin Clotting Time (ECT) |
125.6; 179.1 | — |
Summary
The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.
Eligibility Criteria
Inclusion Criteria
- Either one of the following risk factors is sufficient for inclusion (high risk patient)
- Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), >30 days prior to randomization)
- Previous systemic embolism or at least one of the following risk factors are needed for inclusion: Age ≥75 years
- Symptomatic congestive heart failure
- Impaired left ventricular systolic function
- Diabetes mellitus; Hypertension requiring anti-hypertensive treatment
- In addition to AF the patient must be appropriate for but unable or unwilling to take VKA therapy
Exclusion Criteria
- Presence of a clinically significant valvular heart disease;; Stroke or TIA and/or systemic embolism within the previous 30 days prior to randomization
- Conditions associated with increased risk of major bleeding
Data sourced from ClinicalTrials.gov (NCT00623779). 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.