EUCTR2018-000608-40-IT进行中（未招募）1 期
Aspirin versus Aspirin plus Clopidogrel in Patients Undergoing Transcatheter Aortic ValveReplacement: a Randomized Multicenter Study - No-DAPT-TAVI
AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI0 个研究点目标入组 762 人开始时间: 2021年9月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 762
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
- •1) Patients undergoing an effective and uncomplicated procedure. Effective TAVI intervention means the correct positioning of a single aortic prosthesis in the appropriate anatomic site, with a residual gradient <20 mmHg and in the absence of severe aortic valvular insufficiency. Uncomplicated TAVI intervention means an effective implantation of prostheses in the absence of strokes, major bleeding types 3b, 3c or 5 according to the BARC definition, vascular complications according to the VARC definition (Table 1), coronary obstruction, or acute valvular dysfunction requires a new implant of prosthesis or surgical conversion.
- •2) Age> 18 years
- •3) Obtaining informed consent
- •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 462
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1) Need of anticoagulant therapy;
- •2) Medicated stent implant within 12 months prior to randomization;
- •3) Note or suspected hypersensitivity to ASA or clopidogrel;
- •4) Women of childbearing age;
- •5) Participation in another study protocol;
- •6) Ejection fraction <20%;
- •7) Acute coronary syndrome within the year preceding randomization;
- •8) Major bleeding event within 5 years from randomization;
- •9) Hemoglobin levels lower than 8 mg / dl;
- •10) History of asthma induced by administration of acetylsalicylates;
- •11) Evidence of gastric ulcer, duodenal or esophageal ulcer with active bleeding or clinically significant gastrointestinal bleeding within 8 weeks prior to randomization;
- •12) Any constitutional or acquired haemorrhagic disease;
- •13) Impaired renal function defined by eGFR values ¿¿<30 mL / min / 1.73 m2;
- •14) Hepatic pathology defined by serum ALT (SGPT), AST (SGOT), or alkaline phosphatase levels higher than 3 times the upper limit of normality;
- •15) Concomitant treatment with methotrexate at doses of 15 mg / week or more;
- •16) Pre-existing mastocytosis, in patients in whom the use of acetylsalicylic acid can induce serious hypersensitivity reactions;
- •17) Documented or suspected active malignant neoplasia or previous history, within 2 years prior to randomization;
- •18) Patients who must or want to continue taking illicit drugs or drugs that can interfere with the proper conduct of the study;
- •19) Chronic abuse of alcohol or drugs or any condition that in the judgment of the investigator doctor makes an unreliable subject in correctly completing the procedures of the study;
- •20) Any other clinical condition that would endanger the safety of patients in participating in the study or that could prevent the subjects from adhering to the protocol.
研究者
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