JPRN-jRCTs071180025招募中4 期
Edoxaban Regimen for the Prevention of Subclinical Valve Leaflet Thrombosis in Patients with Atrial Fibrillation Following Transcatheter Aortic Valve Implantation - ENRICH-TAVI
Kenichi Tsujita0 个研究点目标入组 100 人开始时间: 2019年2月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. 20 years and older
- •2. Patients with severe aortic stenosis who are scheduled to undergo TAVI
- •3. Patients who need anticoagulation therapy due to atrial fibrillation
- •4. Patients with the informed consent
排除标准
- •1. Patients with the contraindications of Edoxaban
- •(A) Patients with a history of hypersensitivity to the components of edoxaban
- •(B) Patients with serious bleeding symptoms
- •(C) Severe liver disease with blood coagulation abnormalities and clinically important bleeding risk
- •(D) Acute bacterial endocarditis
- •(E) Severe renal dysfunction (creatinine clearance less than 15 mL / min)
- •2. Valvular atrial fibrillation (rheumatic mitral valve stenosis or artificial valve replacement)
- •3.Patients who judged unsuitable for participating in the study on the following items;
- •(A) High bleeding risk
- •1). Congenital or acquired hemorrhagic disease
- •2). Active ulcerative digestive tract disease
- •3). Thrombocytopenia
- •4). platelet related diseases
- •5). History of hemorrhagic stroke within 3 months
- •6). Severe hypertension with poor control
- •7). Patients with recent surgical history (etc. brain, spinal cord, ophthalmic)
- •(B) Severe liver disease
- •(C) Pregnant women
- •(D) Lactating women
研究者
相似试验
已完成
不适用
on-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients with Venous Thromboembolism in EuropeDRKS00007934Daiichi Sankyo Europe GmbH2,809
已完成
不适用
Clinical study on the usefullness of edoxaban tosilate hydrate to portal vein thrombosis complicated with chronic liver diseasePortal vein thrombosisJPRN-UMIN000030108Kanazawa University Hospital20
进行中（未招募）
1 期
A Phase IV study on impact of Edoxaban treatment in Italian cancer patients with venous thromboembolism during antineoplastic therapyVenous thromboembolism event associated with cancerMedDRA version: 21.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866MedDRA version: 21.1Level: PTClassification code 10028997Term: Neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-003833-14-ITGRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)300
进行中（未招募）
1 期
A pilot study on Edoxaban for the resolution of left atrial thrombosis in patients with non-valvular atrial fibrillatioon-Valvular Atrial FibrillationMedDRA version: 20.0Level: LLTClassification code 10016566Term: Fibrillation atrialSystem Organ Class: 100000004849EUCTR2015-004847-37-ITFONDAZIONE G. D'ANNUNZIO, CHIETI25
已完成
不适用
on-interventional study on Edoxaban treatment in routine clinical practice for patients with non valvular atrial fibrillatioMedDRA - 10003658: Atrial fibrillationI48Atrial fibrillation and flutterDRKS00007912Daiichi Sankyo Europe GmbH13,980