EUCTR2019-001336-62-IT招募中1 期
Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery - The ASPIRE-AF trial - ASPIRE-AF Trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 2,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients are eligible if they: 1. underwent noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days;
- •2. have had =1 episode of clinically important perioperative atrial fibrillation or flutter (AF);
- •3. are in sinus rhythm at the time of randomization;
- •4. have any of the following high-risk criteria: a. age 55-74 years plus either established cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score =3; or b. age =75 years;
- •5.provide written 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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Patients are excluded if they fulfill any of the following criteria: 1. have a history of documented AF before noncardiac surgery; 2. need long-term therapeutic anticoagulation (e.g., mechanical valve); 3. ongoing need for long-term dualantiplatelet treatment; 4. have a contraindication to anticoagulation; 5. have severe renal insufficiency (i.e., eGFR <30 ml/min); 6. have had an acute stroke in the preceding 3 months; 7. underwent cardiac surgery in the preceding 3 months; 8.have a history of intracranial, intraocular, or spinal bleeding; 9. have hemorrhagic disorder or bleeding diathesis; 10. are expected to be non-compliant with follow-up;11. have a known life expectancy of <1 year due to concomitant disease; 12. women who are pregnant, breastfeeding, or of childbearing potential and not taking effective contraception; or 13. were previously enrolled in the trial
研究者
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