Phase 3
N=2,199
Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02072434 ↗Enrolled (actual)
2,199
Serious AEs
7.8%
Results posted
Mar 2019
Primary outcome: Primary: Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up — 0.5; 1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Edoxaban (Drug); Warfarin (Drug); Enoxaparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up |
0.5; 1 | — |
| PRIMARY Percentage of Participants With Composite Endpoints of Major and Clinically-relevant Non-major (CRNM) Bleeding |
1.5; 1 | — |
| SECONDARY Percentage of Participants With Composite Endpoints of Stroke, SEE, MI, CV Mortality, and Major Bleeding |
0.7; 1.4 | — |
Summary
The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.
Eligibility Criteria
Inclusion Criteria
- Has signed informed consent
- Is older than minimum legal adult age (country specific)
- Has had ongoing AF lasting at least 48 hrs but <= 12 months (with or without valvular heart disease)
- Has treatment plan that includes for electrical cardioversion
- Has NVAF or other specific valvular heart diseases (eg, mitral valve prolapse, mitral valve regurgitation, and aortic valve disease)
Exclusion Criteria
- Has AF that is transient or reversible
- Has contraindicated condition, ie, conditions considered to be formal indication for conventional anticoagulation
- Has a history of left atrial appendage (LAA) closure
- Has a known thrombus in LAA, the left atrial, left ventricle or aorta - or an intracardial mass
- Has had myocardial infarction (MI), stroke, acute coronary syndrome (ACS), or percutaneous coronary intervention (PCI) within the past 30 days
- Has any contraindication to anticoagulant agents
- Has had protocol-defined signs of bleeding or conditions associated with high risk of bleeding that would preclude participation
- Is receiving, or plans to receive during the study period, dual antiplatelet therapy (DAPT) or invasive procedures (other than routine endoscopy) in which bleeding would be anticipated
- Has received prohibited concomitant medication or therapy
- Has had protocol-defined signs of bleeding or high
- Has inadequate liver, kidney, and blood test results
- Received any investigational drug or device within the past 30 days or plans to during the study period
- Has reproductive potential and does not agree to take proper contraceptive measures
- Has active cancer requiring chemotherapy/radiation/major surgery within the next 3 months
- Has significant active concurrent medical illness or infection or life expectancy less than 6 months
- In the opinion of the investigator, is unlikely to comply with the protocol or complete the study, has had drug or alcohol dependence within the past year, or has any other condition that might place the participant at increased risk of harm
- Is a participant in the United States after January 2015 with creatinine clearance (CrCL) greater than 95 mL/minute
Data sourced from ClinicalTrials.gov (NCT02072434). 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.