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Clinical Trials/EUCTR2008-004522-16-SE
EUCTR2008-004522-16-SEActive, not recruitingNot Applicable

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP, MULTI-CENTER, MULTI-NATIONAL STUDY FOR EVALUATION OF EFFICACY AND SAFETY OF DU-176B VERSUS WARFARIN IN SUBJECTS WITH ATRIAL FIBRILLATION – Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation (ENGAGE-AF) - ENGAGE AF TIMI-48

Daiichi Sankyo Pharma Development0 sites20,500 target enrollmentStarted: November 26, 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
20,500
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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 electrocardiographic reading [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 of = 2. The CHADS2 scoring is performed by assigning 1 point each for a history of congestive heart failure, hypertension, age = 75 years, or diabetes mellitus; and by assigning 2 points for history of stroke or TIA.
  • •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;

Investigators

Sponsor
Daiichi Sankyo Pharma Development

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