Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Heparin ADP by Multiplate
研究概览
简要总结
All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before.
A cut off value has previously been established. Only low-responders with Multiplate values above the cut off value are included in the study. The patients are randomized to either clopidogrel 150 mg once daily or Prasugrel 10 mg (age > 75 og bodyweight < 60 kg 5 mg)once daily for 30 days after the procedure.
Follow up will be at 30 days after PCI were another MULTIPLATE test will be performed.
Primary endpoint:Platelet inhibition (by MULTIPLATE) after 30 days of intensified antiplatelet therapy.
Clinical endpoints such as bleeding complications (GUSTO, TIMI) during treatment, and major adverse cardiac events (MACE) at 30 days will be collected and reported but the study size does not allow for formal statistical analysis The study ends by the 30 days follow up visit and all patients continue with clopidogrel 75 mg once daily for another 11 months (not study related)
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
- •PCI with stenting and Multiplate hep-ADP > 70 U despite clopidogrel loading
排除标准
- •need for vit K antagonist
- •women with childbearing potential
- •breastfeeding women
- •Planned surgery within 6 months
- •Intolerance to clopidogrel, prasugrel or aspirin
- •previous stroke
研究组 & 干预措施
clopidogrel
clopidogrel 150 mg once daily for 30 days (and then 75 mg for additional 11 months - not study related)
干预措施: clopidogrel (Drug)
Prasugrel
Prasugrel 10 mg once daily for 30 days (and then clopidogrel 75 mg once daily for additional 11 months - not study related)
干预措施: Prasugrel 10 mg (Drug)
结局指标
主要结局
Heparin ADP by Multiplate
时间窗: 30 days
Test of platelet inhibition (ADP receptor mediated) after 30 days of intensifiet anti platelet therapy
次要结局
未报告次要终点
研究者
Lene Holmvang
MD DMSc
Rigshospitalet, Denmark
