EUCTR2009-015013-46-IT进行中（未招募）1 期
Aspirin and Tranexamic Acid for Coronary Artery Surgery Trial - ATACAS
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
- 4,600
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. Males and females, age 18 years and over
- •2. Written, informed consent
- •3. Elective coronary artery surgery (on-pump or off-pump)
- •4. Patient is at increased risk of major complications, defined by any of:
- •· Age ³70 years
- •· Left ventricular impairment (fractional area change <20%, ejection fraction
- •<40%, or at least moderate impairment on ventriculography)
- •· Concomitant valvular or aortic surgery
- •· Aneurysmectomy
- •· Repeat cardiac surgery (re-do”)
- •· Chronic obstructive pulmonary disease
- •· Renal impairment (se. creatinine >150 mmol/l or creatinine clearance <45
- •· Obesity (body mass index >25 kg/m2)
- •· Pulmonary hypertension (mPAP >25 mmHg)
- •· Peripheral vascular disease.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •1. Poor (English) language comprehension
- •2. Clinician preference for antifibrinolytic therapy
- •3. Urgent surgery for unstable coronary syndromes where for clinical reasons
- •antiplatelet medication cannot be discontinued
- •4. Active peptic ulceration
- •5. Allergy or contraindication to aspirin or tranexamic acid
- •6. Aspirin therapy within 4 days of surgery
- •7. Warfarin or clopidogrel therapy within 7 days of surgery, or GIIb/IIIa antagonists
- •within 24 h of surgery
- •8. Thrombocytopaenia or any other known history of bleeding disorder
- •9. Severe renal impairment (serum creatinine >250 mmol/l, or estimated creatinine
- •clearance <25 ml/min)
- •10. Recent haematuria
- •11. Thromboembolic disease relating to: history of postoperative or spontaneous
- •pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability
- •(eg. Lupus anticoagulant, protein C deficiency)
- •12. Pregnancy.
研究者
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