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Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI) (PRO-GR-4)

2011年9月29日 更新者:Dimitrios Alexopoulos、University of Patras

Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)and Presenting With High Platelet Reactivity, as Assessed With a Point of Care Assay, After 600mg Clopidogrel Loading Dose

This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention and presenting high platelet reactivity as assessed with the Verify Now P2Y12 assay-Accumetrics(Platelet Reactivity Units -PRU≥235) at 2 hours post-clopidogrel 600mg LD (Day 0), as assessed with the Verify Now P2Y12 assay, will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:

Group Α: Clopidogrel 150mg per day,starting from Day 1 until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg immediate loading (on Day 0) followed by 10mg/day starting from Day 1 until Day 5 (5 days after randomization).

Platelet reactivity assessment will be performed 2 hours after randomization (Day 0), 24 h after randomization (Day 1) and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (预期的)

35

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Patras、希腊、26500
        • Patras University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 90年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age ≥18 years old
  2. Patients with STEMI undergoing primary PCI with stenting
  3. Platelet reactivity in PRU ≥235 2 hours post 600 mg clopidogrel loading dose
  4. Informed consent obtained in writing

Exclusion Criteria:

  1. Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 5.
  2. Pregnancy
  3. Breastfeeding
  4. Inability to give informed consent or high likelihood of being unavailable until Day 5.
  5. Cardiogenic shock
  6. Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (pseudoaneurysm, arteriovenous shunt, retroperitoneal bleeding or hematoma >5 cm at the arterial catheter insertion site), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding).
  7. Unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3) or planned staged PCI in the next 5 days after randomization
  8. Requirement for oral anticoagulant prior to the Day 5
  9. Current or planned therapy with other thienopyridine class of ADP receptor inhibitors.
  10. Known hypersensitivity to prasugrel or ticagrelor
  11. History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
  12. Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on thienopyridine therapy.
  13. Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
  14. Thrombocytopenia (<100.000 / μL) at randomization
  15. Anaemia (Hct <30%) at randomization
  16. Polycythaemia (Hct > 52%) at randomization
  17. Periprocedural IIb/IIIa inhibitors administration
  18. Severe allergy to contrast agent, unfractionated heparin, enoxaparin or bivalirudin that cannot be adequately premedicated.
  19. Recent (< 6 weeks) major surgery or trauma, including GABG.
  20. Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
  21. INR>1.5 at randomization

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Prasugrel
Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5
Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5
有源比较器:Clopidogrel
Clopidogrel 150mg/day starting from Day 1 until Day 5
Clopidogrel 150mg/d starting from Day 1

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Platelet reactivity
大体时间:24 hours post randomization (Day 1)
Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization
24 hours post randomization (Day 1)

次要结果测量

结果测量
措施说明
大体时间
Platelet reactivity
大体时间:2 hours post randomization (Day 0)
Platelet Reactivity assessed by VerifyNow P2Y12 assay 2 hours post randomization
2 hours post randomization (Day 0)
Platelet reactivity
大体时间:5 days post randomization (Day 5)
Platelet reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization
5 days post randomization (Day 5)
Hyporesponsiveness rate
大体时间:2 hours post randomization (Day 0)
Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)2 hours post randomization
2 hours post randomization (Day 0)
Hyporesponsiveness rate
大体时间:24 hours post randomization (Day 1)
Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)24 hours post randomization
24 hours post randomization (Day 1)
Hyporesponsiveness rate
大体时间:5 days post randomization (Day 5)
Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)5 Days post randomization
5 days post randomization (Day 5)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年4月1日

初级完成 (实际的)

2011年9月1日

研究完成 (实际的)

2011年9月1日

研究注册日期

首次提交

2011年4月15日

首先提交符合 QC 标准的

2011年4月19日

首次发布 (估计)

2011年4月20日

研究记录更新

最后更新发布 (估计)

2011年9月30日

上次提交的符合 QC 标准的更新

2011年9月29日

最后验证

2011年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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