NCT03284827已完成4 期
a Multicenter, Randomized, Open-label, Active-treatment, Controlled Trial to Compare the Efficacy of NOAC With Edoxaban vs. Dual Antiplatelet Therapy (DAPT) for Prevention of Leaflet Thrombosis (Documented by Cardiac CT Imaging) and Cerebral Embolization (Documented With Brain DW-MRI Imaging) in Patients Without an Absolute Indication for Chronic OAC After Successful TAVR
Duk-Woo Park, MD5 个研究点 分布在 3 个国家目标入组 235 人开始时间: 2018年3月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 235
- 试验地点
- 5
- 主要终点
- an incidence of leaflet thrombosis
研究概览
简要总结
This trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs. dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac CT imaging) and cerebral embolization (documented with brainDiffusion-weighted (DW) magnetic resonance (MR) imaging) in patients without an absolute indication for chronic oral anticoagulation (OAC) after successful transcatheter aortic valve replacement(TAVR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 19 years of age or older with successful TAVR procedure
- •either native valve or valve-in-valve with any approved/marketed device
- •A successful TAVR is defined as device success according to the VARC-2 criteria:
- •correct positioning of a single prosthetic heart valve into the proper anatomical location AND
- •Intended performance of the prosthetic heart valve (no prosthesis- patient mismatch* and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, no moderate or severe prosthetic valve regurgitation AND
- •absence of periprocedural complications (any type of stroke, life-threatening bleeding, acute coronary artery obstruction requiring intervention, major vascular complication requiring intervention, unresolved acute valve thrombosis, or any requirement of a repeat procedure.
- •Patients who voluntarily participated in the written agreement
排除标准
- •Any atrial fibrillation with an indication for chronic OAC.
- •An ongoing indication for OAC or any other indication for continued treatment with any OAC
- •Any ongoing indication for DAPT (recent acute coronary syndrome or PCI within 12 months)
- •Planned coronary or vascular intervention or major surgery
- •Clinically significant bleeding patients
- •The risk of bleeding increased due to the following reasons at the time of TAVR procedure, i. history of gastrointestinal ulcers within 1 month ii. Malignant tumor with high risk of bleeding iii. Brain or spinal cord injury within 1 month iv. History of intracranial or intracerebral hemorrhage within 12 months v. Esophageal varices vi. Arteriovenous malformation vii. Vascular aneurysms viii. Spinal cord vascular abnormalities or intracerebral vascular abnormalities ix. Active bleeding x. Hemoglobin level <7.0 g/dL or platelet count ≤ 50,000 / mm3 xi. History of major surgery within 1 month
- •Clinically overt stroke within the last 3 months
- •Moderate and severe hepatic impairment, and any hepatic disease associated with coagulopathy
- •Severe renal impairment (CrCl by Cockcroft-Gault equation<15 mL/min per 1.73 m2), chronic dialysis, or post-TAVR unresolved acute kidney injury
- •Terminal illness with life expectancy <6 months
- •Hypersensitivity to the main component or constituents of Edoxaban
- •Severe hypertensive patient
- •Patient who received prosthetic heart valve replacement for which anticoagulant therapy is essential
- •Moderate to severe mitral stenosis
- •Pulmonary embolism requiring thrombolysis or pulmonary embolectomy
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
- •Pregnancy test results are positive (all pregnant women should undergo urinary human chorionic gonadotropin (hCG) testing within 7 days prior to screening and / or randomization) or during pregnancy or lactation
- •Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •History of hypersensitivity to Edoxaban, Aspirin or clopidogrel
- •Current or history of Aspirin- or NSAIDs-induced asthma
- •Patients who are using Methotrexate at doses of 15mg or more per week
- •Patients who have unsuitable condition to undergo Brain MRI(Magnetic resonance imaging) and/or Cardiac CT(computed tomography) (e.g., tremor from Parkinson's disease). This is at the discretion of investigators.
研究组 & 干预措施
NOAC
Experimental
60 mg once daily
干预措施: NOAC (Drug)
DAPT
Active Comparator
clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD)
干预措施: DAPT (Drug)
结局指标
主要结局
an incidence of leaflet thrombosis
时间窗: 6-month
an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging
次要结局
- Myocardial infarction(6-month)
- Death(6-month)
- Stroke or transient ischemic attack(6-month)
- the number of new lesions on brain DW-MRI scans(6-month)
- Bleeding event(6-month)
- The change of Echocardiographic parameter(6-month)
- New lesion volume on MRI scans(6-month)
- The change of neurological and neurocognitive function(6-month)
研究者
Duk-Woo Park, MD
Professor
Asan Medical Center
研究点 (5)
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