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临床试验/NCT01135667
NCT01135667已完成4 期

Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention

Lene Holmvang1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

发起方
Lene Holmvang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lene Holmvang

MD DMSc

Rigshospitalet, Denmark

研究点 (1)

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