ate development study which compares the effectiveness and safety of a not yet approved drug called edoxaban versus a widely-used and approved drug called warfarin in patients with an abnormal heart beat disease called atrial fibrillation. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving) and is being conducted in many countries around the world

Conditions: Reduction of Stroke and/or systemic embolic event (SEE) in subjects with atrial fibrillation (AF).
MedDRA version: 14.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2008-004522-16-DK

Lead Sponsor: Daiichi Sankyo Pharma Development

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20500

Inclusion Criteria

1. Male or female subjects with age = 21 years;
2. Able to provide written informed consent;
3. History of AF documented by any electrical tracing (routine 12-lead
electrocardiogram [ECG], Holter monitor [continuous ECG recording] rhythm
strip, intracardiac electrogram, or pacemaker [PM] or implantable cardiac
defibrillator [ICD] interrogation) within the prior 12 months and for which
anticoagulation therapy is indicated and planned for the duration of the study;
· Subjects with AF includes subjects with paroxysmal, persistent, or
permanent AF and subjects with or without previous VKA (including
warfarin) experience (it is anticipated that approximately 40% of subjects
will be VKA-naive);
4. Subjects must have a CHADS2 index score = 2. The CHADS2 scoring is
performed by assigning 1 point each for a history of congestive heart failure,
hypertension, age ³ 75 years, or diabetes mellitus; and by assigning 2 points for
history of stroke or TIA (Appendix 17.1).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14350

Exclusion Criteria

2. Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve (subjects with bioprosthetic heart valves and/or valve repair can be included);
• However, subjects with AF and valvular heart diseases such as mitral valve prolapse, mitral valve regurgitation, and aortic valve disease are allowed in the study;
7. Subjects with conditions associated with high risk of bleeding such as past history of intracranial (spontaneous or traumatic), or spontaneous intraocular, spinal, retroperitoneal, or intra-articular bleeding; overt gastrointestinal (GI) bleeding or active ulcer within the previous year; recent severe trauma, major surgery, or deep organ biopsy within the previous 10 days; active infective endocarditis; uncontrolled hypertension (blood pressure [BP] above 170/100 mmHg); or hemorrhagic disorder including known or suspected hereditary or acquired bleeding or coagulation disorder;
10. Subjects receiving prohibited concomitant medications (fibrinolytics, non-study anticoagulants other than those used as a bridge to/from study drug, chronic oral or parental non-aspirin NSAID (use of NSAIDs via other routes are not restricted) use for = 4 days/week, and potent P-gp inhibitors as defined for this study;
22. Subjects with the following diagnoses or situations:
• Active malignancy (diagnosed within 5 years) except for adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g., cervical cancer in situ);
• Treatment with cancer therapy (drug, radiation and/or surgery) within the last 5 years;
• Significant active concurrent medical illness or infection;
• Life expectancy < 12 months;