A Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans (ETCH)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Preconditioning |
Procedure: Coronary occlusion with balloon inflation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Controlled, Open Label Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans |
- Degree of ST-segment elevation by intracoronary ECG during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ] [ Designated as safety issue: No ]
- Degree of ST-segment elevation by surface ECG during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ] [ Designated as safety issue: No ]
- Maximum inflation time tolerated following coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ] [ Designated as safety issue: No ]This is defined as the amount of time the patient tolerates having loss of coronary flow in the target coronary artery during balloon inflation.
- Time to ST-segment elevation during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ] [ Designated as safety issue: No ]
- Angina score during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ] [ Designated as safety issue: No ]This will be reported by the study subject during coronary balloon occlusion based on a validated pain scale.
- Wall motion on chest wall echocardiography before and during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ] [ Designated as safety issue: No ]
- Strain rate on chest wall echocardiography before and during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ticagrelor
Coronary occlusion with balloon inflation
|
Procedure: Coronary occlusion with balloon inflation |
|
Active Comparator: Clopidogrel
Coronary occlusion with balloon inflation
|
Procedure: Coronary occlusion with balloon inflation |
Eligibility| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Michael Luna, MD | 214-590-5028 | michael.luna@utsouthwestern.edu |
| Contact: James de Lemos, MD | 214-645-7521 | james.delemos@utsouthwestern.edu |
| United States, Texas | |
| Dallas Veterans Affairs Medical Center | Not yet recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Michael Luna, MD 214-590-5028 michael.luna@utsouthwestern.edu | |
| Principal Investigator: Jeff Hastings, MD, MS | |
| UT Southwestern Medical Center | Not yet recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Michael Luna, MD 214-590-5028 michael.luna@utsouthwestern.edu | |
| Contact: James de Lemos, MD 214-645-7521 james.delemos@utsouthwestern.edu | |
| Principal Investigator: Michael Luna, MD | |
| Principal Investigator: | James de Lemos, MD | UT Southwestern Medical Center |
More Information
No publications provided
| Responsible Party: | James De Lemos, Professor of Medicine, University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT01743937 History of Changes |
| Other Study ID Numbers: | AZUTSW |
| Study First Received: | December 3, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by University of Texas Southwestern Medical Center:
|
Ischemic preconditioning Ticagrelor Antiplatelet therapy Acute coronary syndrome |
Additional relevant MeSH terms:
|
Ischemia Pathologic Processes Clopidogrel Ticagrelor Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions |
Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013