CTRI/2012/07/002767尚未招募4 期
Aspirin and tranexamic acid for coronary artery surgery trial. A collaborative project conducted by the Australian and New Zealand College of Anaesthetist Trials Group (ANZCA TG), and the NHMRC centre for clinical Research Excellence in Therapeutics
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 4,600
- 试验地点
- 3
- 主要终点
- A composite endpoint including 30-day mortality or major ischaemic morbidity (myocardial infarction, stroke, pulmonary embolism, renal failure, bowel infarction)
研究概览
简要总结
A total of 4,600 people having coronary artery bypass graft surgery will participate in this project. Whilst surgery offers benefit to the majority ofpatients, a small proportion have serious complications (such as heart attack, stroke, infection or even death). Each of these can have a marked effect on quality of life. The purpose of this project is to study the effects of two medications, each of which may reduce complications associated with your heart surgery. The two drugs being tested are aspirin and tranexamic acid (TA). Aspirin and / or TA may protect against some of these complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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 >70 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-doâ€) • Chronic obstructive pulmonary disease • Renal impairment (se.
- •creatinine >150 micromol/l or creatinine clearance <45 ml/min) • Obesity (body mass index >25 kg/m2) • Pulmonary hypertension (mPAP >25 mmHg) • Peripheral vascular disease.
排除标准
- •1.Poor 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 ïmol/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.
结局指标
主要结局
A composite endpoint including 30-day mortality or major ischaemic morbidity (myocardial infarction, stroke, pulmonary embolism, renal failure, bowel infarction)
时间窗: 30 days and 1 year
次要结局
- Secondary Endpoints((i)30-day mortality)
研究者
研究点 (3)
Loading locations...
相似试验
尚未招募
4 期
A prospective, randomised, double blind, factorial trial testing whether aspirin, tranexamic acid, or both, can reduce mortality and/or major morbidity after elective coronary artery surgery.CTRI/2012/07/002767ational Health and Medical Research Council4,600
进行中（未招募）
1 期
Aspirin and Tranexamic Acid for Coronary Artery Surgery TrialCoronary Artery Bypass GraftingMedDRA version: 15.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersEUCTR2009-015013-46-ITALFRED HEALTH4,600
已完成
2 期
Multiple Daily Doses Of Aspirin To Overcome Aspirin Hyporesponsiveness Post Cardiac Bypass SurgeryDysfunction Following Cardiac Surgery PostoperativeNCT01618006Hamilton Health Sciences Corporation120
已完成
2 期
Multiple Daily Doses of Aspirin to Overcome Hyporesponsiveness Post Cardiac Bypass Surgery (ASACABG)- Part BPostoperative Dysfunction Following Cardiac SurgeryNCT01902498Hamilton Health Sciences Corporation70
已完成
不适用
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-termAtherosclerotic Cardiovascular DiseaseNCT02697916Duke University15,076