EUCTR2016-003930-26-AT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
适应症
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
- •1. Successful TAVI via transvascular access routes such as 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 mmHg
- •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 AF
- •b) New onset AF (e.g., > 30 seconds documented by ECG)
- •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. Conditions with a high risk of bleeding
- •o This may include but is not limited to: active peptic ulcer with upper
- •gastrointestinal bleeding within last 90 days prior to randomization,
- •malignancy at high risk of bleeding, major intraspinal or intracerebral
- •vascular abnormalities, 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
- •4. Serious unresolved periprocedural complications
- •5. Any contraindication to EITHER Edoxaban OR VKA per local label; this
- •includes hypersensitivity to the active ingredient or to any of the
- •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 than 3 months beyond the first OAC dose.
- •8. Treatment with other investigational (i.e., non-approved) drugs 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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