Randomized, Evaluation of LoNg-term Anticoagulation with Oral Factor Xa Inhibitor versus Vitamin K Antagonist after Mechanical AorTic Valve ReplacEment

Asan Medical Center0 个研究点目标入组 1,300 人开始时间: 待定最近更新: 2021年6月24日

试验速览

阶段: 未知
状态: 尚未招募
发起方: Asan Medical Center
入组人数: 1,300

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 19?(Year) 至 o Limit（—）
性别: All

入选标准

•1. Aged = 19 years with successful mechanical aortic valve replacement
•2. Mechanical heart valve in aortic valve position, for at least 3 months postoperatively
•3. Good performance of prosthetic aortic valve (no prosthesis-patient mismatch and mean aortic valve gradient < 20 mmHg or peak aortic valve velocity < 3 m/sec, no moderate or severe paravalvular/valvular regurgitation) according to VARC-2 criteria
•4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

排除标准

•1.Old generation mechanical valve
•2.History of mechanical valve implantation in the mitral valve, pulmonary valve or tricuspid valve
•3.Valvular atrial fibrillation(atrial fibrillation with moderate-to-severe mitral stenosis)
•4.History of hemorrhagic stroke
•5.Clinically overt stroke within the last 3 months
•6.Renal failure(creatinine clearance <15mL/min) or on hemodialysis
•7.Left ventricular dysfunction: Left ventricular ejection fraction (LVEF) =40%
•8.Moderate and severe hepatic impairment, and any hepatic disease associated with coagulopathy
•9.Clinically significant active bleeding
•10.Bleeding or hemorrhagic disorder
•11.The increased risk of bleeding due to the following reasons:
•1)History of gastrointestinal ulcers or active ulcerations within the last 6 months
•2)History of intracranial or intracerebral haemorrhage within the last 6 months
•3)Spinal cord vascular abnormalities or intracerebral vascular abnormalities
•4)History of the brain, spinal cord or ophthalmic surgery within the last 6 months
•5)History of the brain or spinal cord injury within the last 6 months
•6)oesophageal varices
•7)Arteriovenous malformation
•8)Vascular aneurysms
•9)Malignant tumour with a high risk of bleeding
•12.Bleeding tendencies associated with overt bleeding of;
•ogastrointestinal, genitourinary or respiratory tract;
•ocerebrovascular haemorrhage;
•oaneurysms- cerebral, dissecting aorta;
•opericarditis and pericardial effusions;
•obacterial endocarditis
•13.Hemodynamically unstable or pulmonary embolism required thrombolysis or embolectomy
•14.Combination therapy with other anticoagulants(Unfractionated heparin(UFH), enoxaparin, dalteparin, fondaparinux, etc.) However, the following cases are permitted;
•oSwitching anticoagulants
•oIntravenous UFH to keep central/arterial lines open
•15.Uncontrolled moderate or severe hypertension
•16.Gastrointestinal bleeding within 1year
•17.Anaemia at least one among the conditions(as defined below) is met
•oDiagnosed and documented ongoing anaemia or
•oHemoglobin level <10.0 g/dL or platelet count < 100 x 10 9/L within the last 6 months
•18.Infective endocarditis
•19.Hypersensitivity to the main component or constituents of Apixaban or Vitamin K antagonist
•20.Positive pregnancy test results (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
•21.Moderate to severe mitral stenosis
•22.A genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
•23.The unsuitable condition to the protocol
•24.Actively participating in another drug or device investigational study, which has not completed the primary endpoint follow-up period
•25.Terminal illness with life expectancy <12 months
•26.Vitamin K deficiency
•27.Alcoholic or psychical disorder
•28.Threatened abortion, eclampsia or preeclampsia

研究者

发起方

Asan Medical Center

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