EUCTR2015-001676-21-ES进行中（未招募）1 期
Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events after Trans-Aortic Valve Implantation for Aortic Stenosis: The ATLANTIS trial - ATLANTIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,510
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
- •- Patients undergoing successful TAVI procedure independent of previous anti-thrombotic treatment.
- •- Ability to understand and to comply with the study protocol.
- •- Written informed consent.
- •- Men and women = 18.
- •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 610
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 900
排除标准
- •-Creatinine Clearance < 15mL/min (Cockcroft formula) or patient undergoing dialysis.
- •-Mechanical valves.
- •-Known severe mitral valve stenosis requiring an intervention.
- •-Failure of TAVI procedure necessitating re-operation.
- •-Ongoing major bleeding or vascular complication (such patients may become eligible once stabilised).
- •-Prior history of cerebral haemorrhage with absolute counter-indication for anti-coagulant and platelet treatment (AVK, apixaban).
- •-Cerebral vascular or ischemic incident based on anti-coagulant treatment .
- •-Cardiogenic shock manifested by low cardiac output, dependency on pressor amines, non-invasive ventilation or cardiac assistance.
- •-Surgery with major haemorrhagic risk scheduled during the follow-up period and necessitating a halt to treatment with relays by parenteral anti-thrombotic.
- •-Concomitant disease with life expectancy less than one year.
- •-Concomitant use of prasugrel or ticagrelor.
- •-Concomitant treatment with CYP3A4 inhibitors such as anti-fungal azoles (itracozanole and ketoconazole), macrolides (clarithromycine and telithromycin), protease inhibitors (ritonavir, indinavir, nelfinavir and aquinavir) and nefazadone.
- •-Women of childbearing potential (WOCBP).
- •-Men who are sexually active with WOCBP partners.
- •-Pregnancy and breast feeding.
- •-Participation in another interventional therapeutic trial (medication or medical device) on-going or in the previous 30 days.
- •-Hepatic failure associated with haemostatic anomalies and significant bleeding risk.
- •-Cancer progression.
- •-Inability to give informed consent or high likelihood of being unavailable for follow-up.
研究者
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