Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Serum thromboxane B2
研究概览
简要总结
This is a single-center, open-label, randomized controlled trial. Patients with stable angina pectoris without use of dual antiplatelet therapy or anticoagulation therapy scheduled for coronary artery bypass grafting (CABG) at Karolinska University Hospital in Stockholm, Sweden will be eligible.
This study investigates in patients having undergone CABG whether increasing the dose or the frequency of acetylsalicylic acid (ASA) treatment improves the efficacy of ASA regarding platelet inhibition compared to the standard dosing for cardiovascular prevention (75 mg once daily) in the first three months after surgery. Patients will be randomly assigned to postoperative ASA dose 75mg once daily, 75mg twice daily or 160 mg once daily. The study dose ASA will be started at hospital discharge and continued of three months. Blood samples for serum thromboxane B2 (TxB2) and other analyses will be taken before surgery, before discharge, and after one and three months. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable coronary artery disease
- •≥18 years of age
- •Scheduled to undergo elective CABG surgery
- •Willing to participate and able to provide informed consent
排除标准
- •Intake of drugs other than ASA that are known to influence platelet function, including nonsteroidal anti-inflammatory drugs (NSAIDs, including COX-2 selective anti-inflammatory drugs), GPIIbIIIa inhibitors, clopidogrel, dipyridamole, warfarin or acenocoumarol within 7 days of enrolment
- •Hemorrhagic diathesis or known platelet dysfunction
- •Chronic renal failure requiring dialysis
- •Platelet count outside the 100 000 to 450 000/μL range
- •Haemoglobin < 8g/dl
研究组 & 干预措施
Acetylsalicylic acid 75 mg twice daily
Aspirin 75 mg BID is a new experimental dosing regimen which has shown improved efficiency regarding laboratory parameters in several studies, mainly in diabetic patients.
干预措施: Acetylsalicylic acid (Drug)
Acetylsalicylic acid 160 mg once daily
Aspirin 160 mg OD is an accepted and used dosage after CABG.
干预措施: Acetylsalicylic acid (Drug)
Acetylsalicylic acid 75 mg once daily
Aspirin 75 mg OD is an accepted and used dosage after CABG.
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Serum thromboxane B2
时间窗: 3 months
次要结局
- Multiple electrode aggregometry platelet aggregation(3 months)
研究者
Magnus Dalén
MD, PhD
Karolinska University Hospital