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Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

2013年4月9日 更新者:Dimitrios Alexopoulos、University of Patras

Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI): a Multi-center Randomized Parallel Pharmacodynamic Study.

This is a multi-center, prospective, randomized, single-blind, investigator initiated, pharmacodynamic study of parallel design, performed at 3 institutions (Patras University Hospital; Evangelismos Athens General Hospital; Gennimatas Athens General Hospital).

Patients with ST elevation myocardial infarction (symptom onset < 12 hours), undergoing primary percutaneous coronary intervention, who are antiplatelet naïve (Group A) or present high residual PR (defined as PRU ≥ 208) immediately before primary percutaneous coronary intervention, will be randomized after informed consent, in a 1:1 ratio to either:

Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD )starting 12±6 hours post LD Or Ticagrelor 360mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD Platelet reactivity assessment will be performed at randomization (Hour 0) and at 0.5, 1, 2, 4 hours after randomization, using the VerifyNow assay, in platelet reactivity units (PRU).

Documentation of major adverse cardiac events (death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG) and bleeding (according to Bleeding Academic Research Consortium criteria) will be performed until patient's discharge.

研究概览

研究类型

介入性

注册 (实际的)

83

阶段

  • 第四阶段

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

    • Achaia
      • Rio、Achaia、希腊、26500
        • Cardiology Department 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 95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 (onset of pain < 12 hours) with indication for primary PCI
  3. Antiplatelet naïve or presenting HTPR (≥ 208 PRU) immediately before primary percutaneous coronary intervention
  4. Informed consent obtained in writing

Exclusion Criteria

  • Pregnancy
  • Breastfeeding
  • Inability to give informed consent or high likelihood of being unavailable until the Day 5
  • Cardiogenic shock
  • Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (arteriovenous shunt, retroperitoneal bleeding), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding).
  • Unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3)
  • Known hypersensitivity to ticagrelor
  • History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months.
  • Other bleeding diathesis, or considered by investigator to be at high risk for bleeding
  • Any previous history of stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
  • Thrombocytopenia (< 100.000/μL) at randomization
  • Anaemia (Hct < 30%) at randomization
  • Polycytaemia (Hct > 52%) at randomization
  • Periprocedural IIb/IIIa inhibitors administration
  • Thrombolysis administration
  • Recent (< 6 weeks) major surgery or trauma, including GABG.
  • 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.
  • Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin/rifampicin, phenytoin, carbamazepine).
  • Increased risk of bradycardiac events.
  • Dialysis required.
  • Severe uncontrolled chronic obstructive pulmonary disease
  • Known severe hepatic impairment

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
有源比较器:Ticagrelor 180mg loading dose
Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose
Ticagrelor 180mg loading dose 180mg loading dose
实验性的:Ticagrelor 360mg loading dose
Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose
Ticagrelor 180mg loading dose 180mg loading dose

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 at 1 hour post randomization in Group A, between the 2 treatment arms.
大体时间:1 hour
platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.
1 hour

次要结果测量

结果测量
措施说明
大体时间
1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.
大体时间:1 hour
1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.
1 hour
2. Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B
大体时间:0.5 hour
Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B
0.5 hour
Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B
大体时间:2 hours
Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B
2 hours
Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B
大体时间:4 hours
Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B
4 hours
3. High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 0.5 hour post randomization between the 2 treatment arms, separately for Group A and B
大体时间:0.5 hour
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 0.5 hour post randomization between the 2 treatment arms, separately for Group A and B
0.5 hour
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B
大体时间:1 hour
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B
1 hour
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B
大体时间:2 hours
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B
2 hours
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B
大体时间:4 hours
High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B
4 hours
Occurrence of any 5-day bleeding event (BARC Types 1-5)
大体时间:5 days
Occurrence of any 5-day bleeding event (BARC Types 1-5)
5 days
Occurrence of 5-day MACEs
大体时间:5 days
Occurrence of 5-day MACEs
5 days

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。

调查人员

  • 首席研究员:Dimitrios Alexopoulos, MD、University Hospital of Patras

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

2012年4月1日

初级完成 (实际的)

2013年2月1日

研究完成 (实际的)

2013年2月1日

研究注册日期

首次提交

2012年4月9日

首先提交符合 QC 标准的

2012年4月10日

首次发布 (估计)

2012年4月11日

研究记录更新

最后更新发布 (估计)

2013年4月10日

上次提交的符合 QC 标准的更新

2013年4月9日

最后验证

2013年4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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