Phase 3
Completed N=21,105
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
Stroke · Atrial Fibrillation · Embolism
Source: ClinicalTrials.gov NCT00781391 ↗
Enrolled (actual)
21,105
Serious AEs
49.6%
Results posted
Mar 2015
Primary outcomePrimary: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). — 253; 182; 232 number of participants with event — p=<.0001
Summary
This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). |
382; 292; 335 | <.0001 sig |
| PRIMARY Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). |
382; 292; 335 | <.0001 sig |
| PRIMARY Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). |
382; 292; 335 | <.0001 sig |
| PRIMARY Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). |
382; 292; 335 | <.0001 sig |
| PRIMARY Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). |
383; 296; 337 | .081 |
| SECONDARY Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality |
796; 728; 831 | .0053 sig |
| SECONDARY Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding |
913; 827; 926 | .0109 sig |
| SECONDARY Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality |
985; 949; 1046 | .0168 sig |
| SECONDARY Adjudicated Bleeding Events |
254; 418; 524; 41; 61; 132 | .0009 sig |
Eligibility Criteria
Inclusion Criteria
- 21 years of age or older; male or female.
- Able to provide written informed consent.
- History of documented AF within the prior 12 months
- A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2
Exclusion Criteria
- Transient atrial fibrillation secondary to other reversible disorders
- Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
- Subjects with any contraindication for anticoagulant agents;
- Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
- Females of childbearing potential including the following:
- Females with a history of tubal-ligation
- Females less than 2 years post-menopausal
Data sourced from ClinicalTrials.gov (NCT00781391). 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. Informational only — not medical advice.