EUCTR2016-003930-26-DE进行中（未招募）1 期
Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation – In Atrial Fibrillation. ENVISAGE-TAVI AF - ENVISAGE-TAVI AF
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must satisfy all of the following criteria to be included in the study:
- •1. Successful TAVI via transvascular access routes such as to the femoral, carotid, axillary and subclavian arteries. Other access routes need prior approval per a majority vote from 3 members of the Executive Committee (both Global Lead Investigators and the Daiichi Sankyo Medical Lead or his / her designee). Success is defined as:
- •a. Correct positioning of a single prosthetic heart valve into the proper anatomical location
- •b. Presence of all 3 conditions post TAVI
- •I. Mean aortic valve gradient <20 mm Hg
- •ii. Peak transvalvular velocity <3.0 m/s
- •iii. Aortic valve regurgitation of 2 or less
- •c. No clinically overt stroke
- •d. No uncontrolled bleeding at time of randomization
- •2. Indication for chronic OAC
- •a. Documented pre-existing atrial fibrillation (AF)
- •b. New onset AF (e.g. > 30 seconds documented by ECG recording)
- •3. Provision of signed informed consent
- •4. Age =18 years
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1120
排除标准
- •1. Other conditions with a high risk of bleeding
- •This may include but is not limited to: active peptic ulcer with upper gastrointestinal (GI) bleeding within last 90 days prior to randomization, malignancy at high risk of bleeding, major intraspinal or intracerebral vascular abnormalties, recent unresolved brain or spinal injury, or spinal surgery (recent = within the last 90 days prior to randomization), any intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations or clinically relevant vascular aneurysms.
- •2. Other known bleeding diatheses
- •3. Conditions that make it difficult for the subject to swallow the study medication
- •4. Serious unresolved periprocedural complications
- •5. Any contraindications to either Edoxaban or VKA per local label; this includes hypersensitivity to the active ingredient or to any excipients, or any components of the study medications
- •6. Concomitant treatment with other antithrombotic agents, ASA > 100 mg/day, fibrinolytic therapy, or chronic (> 4 days/week) use of nonsteroidal antiinflammatory drugs (NSAIDs); however, NSAID patches are permitted
- •7. Requirement for dual-antiplatelet therapy (DAPT) at randomization that will be indicated for more than3 month beyond the first OAC dose
- •8. Treatment with other investigational drugs (i.e. non-approved) or devices within 30 days before enrollment or planned use of investigational drugs or devices during the study
- •For full list of Refer to Protocol, section: 4.2
研究者
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