A Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans (ETCH)
A Randomized, Controlled, Open Label Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans
Antiplatelet therapy remains a cornerstone in the treatment of acute and chronic coronary artery disease. Aspirin was the first such therapy to prove its benefits in acute myocardial infarction. Compared to aspirin monotherapy, the combination of aspirin and clopidogrel, a thienopyridine P2Y12 inhibitor, has been demonstrated to reduce adverse event rates among patients with acute coronary syndromes (with or without ST-segment elevation) and those receiving intracoronary stents. In the Triton-TIMI 38 trial a novel thienopyridine, prasugrel, was compared to clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention. Although prasugrel significantly reduced recurrent myocardial infarction, bleeding rates were increased and no improvement in cardiac or all-cause mortality was demonstrated. However, in 2009, the authors of the PLATO trial demonstrated an unexpected cardiovascular mortality benefit with ticagrelor over clopidogrel, an endpoint not previously met by any other antiplatelet agent against an active comparator. Based on the reproducible adverse events seen in the DISPERSE, DISPERSE-2, and PLATO trials, an adenosine-mediated effect of ticagrelor is proposed.
Hypothesis: The aim of this study is to test the hypothesis that ticagrelor produces pharmacologic ischemic preconditioning, an undescribed potential off-label property of ticagrelor that could represent a plausible mechanism for its effects on cardiovascular mortality.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Texas
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Dallas、Texas、美国、75390
- UT Southwestern Medical Center
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Dallas、Texas、美国、75216
- Dallas Veterans Affairs Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Undergoing clinically-indicated PCI for stable or progressive exertional angina without rest angina, ST-segment shift, or elevated CK-MB or troponin-T or I
- Willing and able to give informed consent and to comply with study procedures
- Found to have single or two-vessel obstructive, non-occlusive (≥ 70% but < 100% stenosis), coronary artery disease with plans for treatment of all lesions by PCI
- Target lesion location in the proximal or mid coronary vessel with reference diameter ≥ 2.5 mm
Exclusion Criteria:
- Known allergy to aspirin, clopidogrel, or ticagrelor
- Need for concomitant cardiac procedure, such as valve repair or replacement
- Age ≥ 75
- Concomitant theophylline/aminophylline use
- Baseline ECG with infarct or conduction abnormalities (i.e. LVH with repolarization abnormality, bundle branch block, ST-segment abnormalities)
- Presenting with an ST-segment elevation or non ST-segment elevation myocardial infarction
- Evidence of prior myocardial infarction by cardiac imaging
- Depressed left ventricular systolic function (ejection fraction < 50%)
- Clinical congestive heart failure
- End-stage renal disease
- Presence of coronary collaterals on diagnostic coronary angiography
- Presence of coronary thrombus on diagnostic coronary angiography
- Diffuse obstructive disease (≥ 70% stenosis) in the distal segment of the target vessel
- Left main and/or three-vessel coronary artery disease
- Concomitant need for Warfarin therapy
学习计划
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Ticagrelor
Coronary occlusion with balloon inflation
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有源比较器:Clopidogrel
Coronary occlusion with balloon inflation
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Degree of ST-segment elevation by intracoronary ECG during coronary balloon inflation
大体时间:7-12 days after drug randomization
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7-12 days after drug randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Degree of ST-segment elevation by surface ECG during coronary balloon inflation
大体时间:7-12 days after drug randomization
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7-12 days after drug randomization
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Maximum inflation time tolerated following coronary balloon inflation
大体时间:7-12 days after drug randomization
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This is defined as the amount of time the patient tolerates having loss of coronary flow in the target coronary artery during balloon inflation.
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7-12 days after drug randomization
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Time to ST-segment elevation during coronary balloon inflation
大体时间:7-12 days after drug randomization
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7-12 days after drug randomization
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Angina score during coronary balloon inflation
大体时间:7-12 days after drug randomization
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This will be reported by the study subject during coronary balloon occlusion based on a validated pain scale.
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7-12 days after drug randomization
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Wall motion on chest wall echocardiography before and during coronary balloon inflation
大体时间:7-12 days after drug randomization
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7-12 days after drug randomization
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Strain rate on chest wall echocardiography before and during coronary balloon inflation
大体时间:7-12 days after drug randomization
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7-12 days after drug randomization
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合作者和调查者
合作者
调查人员
- 首席研究员:James de Lemos, MD、UT Southwestern Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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