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

Primary Purpose

Ischemic Preconditioning

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Coronary occlusion with balloon inflation

About this trial

This is an interventional treatment trial for Ischemic Preconditioning focused on measuring Ischemic preconditioning, Ticagrelor, Antiplatelet therapy, Acute coronary syndrome

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dallas Veterans Affairs Medical Center
UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

Coronary occlusion with balloon inflation

Outcomes

Primary Outcome Measures

Degree of ST-segment elevation by intracoronary ECG during coronary balloon inflation

Secondary Outcome Measures

Degree of ST-segment elevation by surface ECG during coronary balloon inflation

Maximum inflation time tolerated following coronary balloon inflation

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

Angina score during coronary balloon inflation

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

Strain rate on chest wall echocardiography before and during coronary balloon inflation

Full Information

NCT ID

NCT01743937

First Posted

December 3, 2012

Last Updated

November 23, 2020

Sponsor

University of Texas Southwestern Medical Center

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01743937

Brief Title

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

Acronym

ETCH

Official Title

A Randomized, Controlled, Open Label Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

Sponsor terminated due to budgetary issue

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Preconditioning

Keywords

Ischemic preconditioning, Ticagrelor, Antiplatelet therapy, Acute coronary syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ticagrelor

Arm Type

Active Comparator

Arm Description

Coronary occlusion with balloon inflation

Arm Title

Clopidogrel

Arm Type

Active Comparator

Arm Description

Coronary occlusion with balloon inflation

Intervention Type

Procedure

Intervention Name(s)

Coronary occlusion with balloon inflation

Primary Outcome Measure Information:

Title

Degree of ST-segment elevation by intracoronary ECG during coronary balloon inflation

Time Frame