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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Texas
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Dallas, Texas, Forenede Stater, 75390
- UT Southwestern Medical Center
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Dallas, Texas, Forenede Stater, 75216
- Dallas Veterans Affairs Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Ticagrelor
Coronary occlusion with balloon inflation
|
|
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Aktiv komparator: Clopidogrel
Coronary occlusion with balloon inflation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Degree of ST-segment elevation by intracoronary ECG during coronary balloon inflation
Tidsramme: 7-12 days after drug randomization
|
7-12 days after drug randomization
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Degree of ST-segment elevation by surface ECG during coronary balloon inflation
Tidsramme: 7-12 days after drug randomization
|
7-12 days after drug randomization
|
|
|
Maximum inflation time tolerated following coronary balloon inflation
Tidsramme: 7-12 days after drug randomization
|
This is defined as the amount of time the patient tolerates having loss of coronary flow in the target coronary artery during balloon inflation.
|
7-12 days after drug randomization
|
|
Time to ST-segment elevation during coronary balloon inflation
Tidsramme: 7-12 days after drug randomization
|
7-12 days after drug randomization
|
|
|
Angina score during coronary balloon inflation
Tidsramme: 7-12 days after drug randomization
|
This will be reported by the study subject during coronary balloon occlusion based on a validated pain scale.
|
7-12 days after drug randomization
|
|
Wall motion on chest wall echocardiography before and during coronary balloon inflation
Tidsramme: 7-12 days after drug randomization
|
7-12 days after drug randomization
|
|
|
Strain rate on chest wall echocardiography before and during coronary balloon inflation
Tidsramme: 7-12 days after drug randomization
|
7-12 days after drug randomization
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: James de Lemos, MD, UT Southwestern Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AZUTSW
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Kliniske forsøg med Coronary occlusion with balloon inflation
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