NCT01466452Unknown2 期
Antiplatelet Effect of Low Doses of Aspirin Taken Every 12 Hours in Patients Undergoing Coronary Artery Bypass Graft and/or Aortic Valve Surgery
Centro Cardiologico Monzino1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin
研究概览
简要总结
This study is a randomized open label study that implies the administration of asprin according to three different regimens.
The aims of the study are:
- to establish whether coronary artery bypass surgery and / or aortic valve replacement surgery with bioprostheses is associated with changes in the rate of platelet regeneration that can reduce the effectiveness of aspirin administered at a dose of 100mg/die in terms of inhibition of platelet biosynthesis of thromboxane A2.
- to determine whether these patients need a different (shorter) interval of administration in order to completely and permanently inhibit the platelet COX-1.
The endpoints of this study are:
- To evaluate the changes in the levels of TXB2 and 12-HETE in serum at 12 and 24 hours after administration of aspirin and the changes in the levels of 11-dehydro TXB2 urinary 8-iso-PGF2 alpha urinary, 2-3 dinor-6-chetoPGF1 alpha, Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent of the study signed
- •coronary artery bypass graft and / or aortic valve replacement surgery with bioprostheses
- •age between 55 and 80
- •ejection fraction > 30%.
排除标准
- •excessive bleeding (> 1000mL / 6 h) or the need of re operation for bleeding
- •perioperative myocardial infarction
- •stroke or renal failure requiring dialysis and need waiting for post-operative anticoagulation
- •patients undergoing coronary artery bypass grafting procedure as a consequence of failed percutaneous coronary intervention
- •patients undergoing off-pump coronary artery bypass graft
- •overt kidney or liver disease
- •therapies that influence the coagulation
- •fertile women
研究组 & 干预措施
Aspirin 100
Active Comparator
干预措施: Aspirin (Drug)
Aspirin 200
Active Comparator
干预措施: Aspirin (Drug)
Aspirin 100 x 2
Active Comparator
干预措施: Aspirin (Drug)
结局指标
主要结局
change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin
时间窗: one year
change in the levels of 12-HETE in serum at 12 and 24 hours after administration of aspirin
时间窗: one year
次要结局
- change in the levels of 11-dehydro TXB2 urinary at 12 and 24 hours after administration of aspirin(one year)
- change in the levels of 8-iso-PGF2 alpha urinary at 12 and 24 hours after administration of aspirin(one year)
- change in the levels of 2-3 dinor-6-chetoPGF1 alpha at 12 and 24 hours after administration of aspirin(one year)
- change in the levels of Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin(one year)
研究者
Alessandro Parolari
Assistant Professor of Cardiac Surgery
Centro Cardiologico Monzino
研究点 (1)
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