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) - ND
- Conditions
- Atrial fibrillationMedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillation
- Registration Number
- EUCTR2008-004522-16-IT
- Lead Sponsor
- DAIICHI SANKIO DEVELOPMENT LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16500
1. Male or female subjects with age ≥ 21 years;
2. Able to provide written informed consent;
3. History of AF documented by a 12-lead electrocardiographic reading and/or continuous electrocardiogram (ECG) (e.g., Holter monitoring)consistent with AF (notation of AF as the abnormal rhythm on the local ECG report with evidence of irregularly irregular rhythm and an absence of P-waves on the ECG for diagnosis of AF) within the prior 12 months and for which anticoagulation therapy is indicated and planned for the duration of the study, including subjects with paroxysmal, persistent, or permanent AF and subjects with or without previous vitamin K antagonist (VKA)(including warfarin) experience (it is anticipated that approximately 40% of subjects will be VKA-naive);
4. A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2, is required to be eligible for the study. 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
1. Male or female subjects with age ≥ 21 years;
2. Able to provide written informed consent;
3. History of AF documented by a 12-lead electrocardiographic reading and/or continuous electrocardiogram (ECG) (e.g., Holter monitoring)consistent with AF (notation of AF as the abnormal rhythm on the local ECG report with evidence of irregularly irregular rhythm and an absence of P-waves on the ECG for diagnosis of AF) within the prior 12 months and for which anticoagulation therapy is indicated and planned for the duration of the study, including subjects with paroxysmal, persistent, or permanent AF and subjects with or without previous vitamin K antagonist (VKA)(including warfarin) experience (it is anticipated that approximately 40% of subjects will be VKA-naive);
4. A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2, is required to be eligible for the study. 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Transient AF secondary to other reversible disorders (e.g., thyrotoxicosis, cardiac or thoracic surgery, pneumonia, severe anemia); 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);
3. Subjects for whom the AF management plan is rhythm control with subsequent discontinuation of oral anticoagulation if sinus rhythm is restored or maintained, including subjects in whom successful electrical or surgical ablation has been performed or is planned during the course of the study;
4. Subjects with any contraindication for anticoagulant agents;
5. Subjects with conditions associated with high risk of bleeding such as past history of spontaneous intracranial, 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;
6. Subjects receiving thienopyridines (such as ticlopidine or clopidogrel) or other non-aspirin antiplatelet agents that cannot be stopped at randomization, or who are anticipated to receive non-aspirin antiplatelet agents as chronic therapy during the study;
;
1. Transient AF secondary to other reversible disorders (e.g., thyrotoxicosis, cardiac or thoracic surgery, pneumonia, severe anemia); 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);
3. Subjects for whom the AF management plan is rhythm control with subsequent discontinuation of oral anticoagulation if sinus rhythm is restored or maintained, including subjects in whom successful electrical or surgical ablation has been performed or is planned during the course of the study;
4. Subjects with any contraindication for anticoagulant agents;
5. Subjects with conditions associated with high risk of bleeding such as past history of spontaneous intracranial, 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;
6. Subjects receiving thienopyridines (such as ticlopidine or clopidogrel) or other non-aspirin antiplatelet agents that cannot be stopped at randomization, or who are anticipated to receive non-aspirin antiplatelet agents as chronic therapy during the study;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method