NCT01103843Unknown不适用
PPD Trial Pilot Study: Plavix, Prasugrel and Drug Eluting Stents
St. Francis Hospital, New York1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in platelet reactivity after switching medication regimen of two thienopyridines- clopidogrel and prasugrel
研究概览
简要总结
- The purpose of this study is to determine the level of inhibition of platelet activation of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the setting of drug eluting coronary stent implantation.
- In subjects with high residual levels of platelet reactivity after receiving either a maintenance or loading dose of either clopidogrel or prasugrel, a cross over of thienopyridine treatment to the alternate medication will occur.
- The study tests the hypothesis that adequate platelet inhibition will occur in subjects who have high levels of platelet reactivity and are subsequently switched from clopidogrel to prasugrel(loading or maintenance dose) without increased episodes of bleeding or MACE events at discharge and 30 days post Percutaneous Coronary Intervention (PCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject presenting for clinically indicated PCI with implantation of at least one drug-eluting stent.
- •No planned use of Glycoprotein IIb/IIIa inhibitors during PCI procedure.
- •Subject must be taking aspirin or enteric coated aspirin 81 mg-325 mg daily.
- •Willing to participate and sign an informed consent.
排除标准
- •Subject older than 75 years of age.
- •Subject weight is 60 kg or less.
- •Subject who have received intravenous eptifibatide or tirofiban within 48 hours prior to PCI or abciximab within 14 days before or during PCI.
- •Subject taking warfarin or with clinical indication to resume warfarin post PCI for any indication.
- •Subject currently requiring daily treatment with NSAID or COX2 inhibitors.
- •Subject with a known platelet disorder.
- •Subject with known active pathological bleeding or heightened risk of bleeding including but not limited to: gastrointestinal bleeding within 6 months, recent surgery or trauma.
- •Subject with a history of a stroke or TIA
- •Subject with pre-PCI hematocrit or platelet count outside the ranges validated for Verify Now P2Y12 test (33-52% and 119.000-502.000/μL, respectively).
- •Subject with a history of hepatic impairment
- •Subject with known NYHA Class III or greater for heart failure.
- •Inability of subject to provide informed consent.
- •Subject with known hypersensitivity or contraindication to clopidogrel, prasugrel or ASA, which would result in inability of patient to adhere to trial protocol.
- •Presence of valvular heart disease left main coronary artery stenosis or urgent need for CABG.
研究组 & 干预措施
Maintenance Dose Arm
Active Comparator
Open label clopidogrel 75 mg daily or prasugrel 10 mg daily
干预措施: Maintenance Dose Arm (Drug)
Loading Dose Arm
Active Comparator
Clopidogrel 600 mg or Prasugrel 60 mg at time of PCI.
干预措施: Loading Dose Arm (Drug)
结局指标
主要结局
Change in platelet reactivity after switching medication regimen of two thienopyridines- clopidogrel and prasugrel
时间窗: 4 hours post medicaton administration
Platelet reactivity will be measured using the Accumetrics Verify Now P2Y12 platelet assay
次要结局
- Occurrence of all bleeding events for subjects enrolled into the trial(24 hours post PCI or at time of discharge and 30 days post PCI)
- Occurrence of all MACE events for subjects enrolled into the trial(24 hours post PCI or at time of discharge and 30 days post PCI)
研究者
研究点 (1)
Loading locations...
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