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.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Texas
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Dallas、Texas、アメリカ、75390
- UT Southwestern Medical Center
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Dallas、Texas、アメリカ、75216
- Dallas Veterans Affairs Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Ticagrelor
Coronary occlusion with balloon inflation
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アクティブコンパレータ:Clopidogrel
Coronary occlusion with balloon inflation
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Degree of ST-segment elevation by intracoronary ECG during coronary balloon inflation
時間枠:7-12 days after drug randomization
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7-12 days after drug randomization
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Degree of ST-segment elevation by surface ECG during coronary balloon inflation
時間枠:7-12 days after drug randomization
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7-12 days after drug randomization
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|
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Maximum inflation time tolerated following coronary balloon inflation
時間枠: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
時間枠:7-12 days after drug randomization
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7-12 days after drug randomization
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|
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Angina score during coronary balloon inflation
時間枠: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
時間枠:7-12 days after drug randomization
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7-12 days after drug randomization
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|
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Strain rate on chest wall echocardiography before and during coronary balloon inflation
時間枠:7-12 days after drug randomization
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7-12 days after drug randomization
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協力者と研究者
協力者
捜査官
- 主任研究者:James de Lemos, MD、UT Southwestern Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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