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A Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans (ETCH)

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ClinicalTrials.gov Identifier: NCT01743937
Recruitment Status : Terminated (Sponsor terminated due to budgetary issue)
First Posted : December 6, 2012
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
James De Lemos, University of Texas Southwestern Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Ischemic Preconditioning Procedure: Coronary occlusion with balloon inflation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open Label Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans
Study Start Date : January 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Degree of ST-segment elevation by intracoronary ECG during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ]

Secondary Outcome Measures :
  1. Degree of ST-segment elevation by surface ECG during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ]
  2. Maximum inflation time tolerated following coronary balloon inflation [ Time Frame: 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.

  3. Time to ST-segment elevation during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ]
  4. Angina score during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ]
    This will be reported by the study subject during coronary balloon occlusion based on a validated pain scale.

  5. Wall motion on chest wall echocardiography before and during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ]
  6. Strain rate on chest wall echocardiography before and during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ]


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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743937


Locations
United States, Texas
Dallas Veterans Affairs Medical Center
Dallas, Texas, United States, 75216
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
AstraZeneca
Investigators
Principal Investigator: James de Lemos, MD UT Southwestern Medical Center

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
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Keywords provided by James De Lemos, 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
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs