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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01743937
Recruitment Status : Terminated (Sponsor terminated due to budgetary issue)
First Posted : December 6, 2012
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
James De Lemos, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE December 3, 2012
First Posted Date  ICMJE December 6, 2012
Last Update Posted Date November 25, 2020
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
Degree of ST-segment elevation by intracoronary ECG during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
  • Degree of ST-segment elevation by surface ECG during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ]
  • 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.
  • Time to ST-segment elevation during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ]
  • 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.
  • Wall motion on chest wall echocardiography before and during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ]
  • Strain rate on chest wall echocardiography before and during coronary balloon inflation [ Time Frame: 7-12 days after drug randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans
Official Title  ICMJE A Randomized, Controlled, Open Label Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Preconditioning
Intervention  ICMJE Procedure: Coronary occlusion with balloon inflation
Study Arms  ICMJE
  • Active Comparator: Ticagrelor
    Coronary occlusion with balloon inflation
    Intervention: Procedure: Coronary occlusion with balloon inflation
  • Active Comparator: Clopidogrel
    Coronary occlusion with balloon inflation
    Intervention: Procedure: Coronary occlusion with balloon inflation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 15, 2018)
18
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2012)
50
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01743937
Other Study ID Numbers  ICMJE AZUTSW
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James De Lemos, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: James de Lemos, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP