KCT0003003已完成未知
Anticoagulant versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 229
研究概览
简要总结
Anticoagulant versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •1.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 Valve Academic Research Consortium (VARC)-2 criteria:
- •(1) correct positioning of a single prosthetic heart valve into the proper anatomical location AND
- •(2) 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
- •(3) 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.
- •2.Patients who voluntarily participated in the written agreement
排除标准
- •1.Any atrial fibrillation with an indication for chronic OAC(Oral anticoagulant)
- •2.An ongoing indication for OAC or any other indication for continued treatment with any OAC
- •3.Any ongoing indication for DAPT (recent acute coronary syndrome or PCI within 12 months)
- •4.Planned coronary or vascular intervention or major surgery
- •5.Clinically significant bleeding patients
- •6.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
- •7.Clinically overt stroke within the last 3 months
- •8.Moderate and severe hepatic impairment, and any hepatic disease associated with coagulopathy
- •9.Severe renal impairment (CrCl by Cockcroft-Gault equation<15 mL/min per 1.73 m2), chronic dialysis, or post-TAVR unresolved acute kidney injury
- •10.Terminal illness with life expectancy <6 months
- •11.Hypersensitivity to the main component or constituents of Edoxaban
- •12.Severe hypertensive patient
- •13.Patient who received prosthetic heart valve replacement for which anticoagulant therapy is essential
- •14.Moderate to severe mitral stenosis
- •15.Pulmonary embolism requiring thrombolysis or pulmonary embolectomy
- •16.Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
- •17.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
- •18.Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •19.History of hypersensitivity to Edoxaban, Aspirin or clopidogrel
- •20.Current or history of Aspirin- or NSAIDs-induced asthma
- •21.Hemophilia
- •22.Patients who are using Methotrexate at doses of 15mg or more per week
- •23.Patients who have unsuitable condition to undergo Brain MRI and/or Cardiac CT (e.g., tremor from Parkinson’s disease) This is at the discretion of investigators
研究者
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