EUCTR2015-001676-21-DE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.
- •-Unsuccessful TAVI requiring re-intervention.
- •-Ongoing major bleeding or vascular complication (patients may become candidate to the study once stabilized).
- •-Prior history of intracranial haemorrhage.
- •-Recent cerebro-vascular event (CVE) or transient ischemic attack on anticoagulant therapy (<6 weeks).
- •-Cardiogenic shock manifested by low cardiac output, vasopressor or respiratory dependence, or mechanical hemodynamic support.
- •-Planned major surgery during follow-up defined as high-bleeding risk according to ESC/EHRA and requiring interruption of the study drug with bridging
- •-Concomitant medical illness (terminal malignancy) that is associated with expected survival less than one year.
- •-Concomitant use of prasugrel or ticagrelor.
- •-Following concomitant treatments that are potent inhibitors of CYP3A4: azole antifungals (itracozanole and ketoconazole), macrolide antibiotics (clarithromycine and telithromycin), and 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.
- •-Currently participating in an investigational drug or another device trial within the previous 30 days.
- •-Known Liver affection associated with coagulopathy and medical significant risk of bleeding.
- •-Uncontrolled cancer with life expectancy of less than one year.
- •-Inability to give informed consent or high likelihood of being unavailable for follow-up.
研究者
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