Phase 2
N=1,146
A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation
Atrial Fibrillation · Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT00504556 ↗Enrolled (actual)
1,146
Serious AEs
5.8%
Results posted
Mar 2015
Primary outcome: Primary: Adjudicated Incidence of Bleeding Events — 5.5; 12.7; 7.3; 18.3 percent of subjects with outcome event — p=.367
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Edoxaban (DU-176b) (Drug); warfarin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjudicated Incidence of Bleeding Events |
5.5; 12.7; 7.3; 18.3; 8.0; 3.0 | .367 |
| PRIMARY Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA) |
1.3; 0.9; 2.6; 1.7; 1.2; 0.9 | — |
| SECONDARY Incidence of Major Adverse Cardiac Events MACE) |
1.7; 2.5; 4.3; 1.1; 2.4; .4 | — |
| SECONDARY Effects on Biomarker D-dimer |
-225; -187.8; -100.5; -129.8; -160.7 | — |
| SECONDARY Effects on Biomarker Prothrombin Fragments |
-23.5; -47.4; -51.4; 6.4; -74.6 | — |
| SECONDARY Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b |
10.3; 21.2; 39.6; 75.7; 84.9; 173.0 | — |
| SECONDARY Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b |
825; 1729; 1728; 3301 | — |
| SECONDARY Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b |
1.46; 1.91; 2.42; 3.28 | — |
| SECONDARY Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b |
-40.3; -40.2; -44.4; -45.2 | — |
| SECONDARY Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b |
14.0; 15.4; 18.3; 19.6 | — |
| SECONDARY Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b |
0.6; 0.4; 2.0; 2.1 | — |
| SECONDARY Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b |
0.05; 0.03; 0.17; 0.26 | — |
Summary
This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 to 80 years old.
- Able to provide written informed consent.
- Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)
- A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2
Exclusion Criteria
- Subjects with mitral valve disease or previous valvular heart surgery
- Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin
- Known or suspected hereditary or acquired bleeding or coagulation disorder
Data sourced from ClinicalTrials.gov (NCT00504556). 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.