Ischemic PreconditioningPhase 4ETCHNCT01743937
A Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans
A Phase 4 study testing Coronary occlusion with balloon inflation in people with Ischemic Preconditioning, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Ischemic Preconditioning
- What is being tested?
- Coronary occlusion with balloon inflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2013to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dallas Veterans Affairs Medical Center
Dallas, Texas, 75216
UT Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: 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.
- Conditions
- Ischemic Preconditioning
- Being tested
- Coronary occlusion with balloon inflation
- Keywords
- Ischemic preconditioning, Ticagrelor, Antiplatelet therapy, Acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary occlusion with balloon inflationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Active comparator | Coronary occlusion with balloon inflation Receives: Procedure: Coronary occlusion with balloon inflation |
| Clopidogrel | Active comparator | Coronary occlusion with balloon inflation Receives: Procedure: Coronary occlusion with balloon inflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of ST-segment elevation by intracoronary ECG during coronary balloon inflation
Measured: 7-12 days after drug randomization
Secondary outcomes (6)
Degree of ST-segment elevation by surface ECG during coronary balloon inflation
Measured: 7-12 days after drug randomization
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.
Measured: 7-12 days after drug randomization
Time to ST-segment elevation during coronary balloon inflation
Measured: 7-12 days after drug randomization
Angina score during coronary balloon inflation
This will be reported by the study subject during coronary balloon occlusion based on a validated pain scale.
Measured: 7-12 days after drug randomization
Wall motion on chest wall echocardiography before and during coronary balloon inflation
Measured: 7-12 days after drug randomization
Strain rate on chest wall echocardiography before and during coronary balloon inflation
Measured: 7-12 days after drug randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Sponsor terminated due to budgetary issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic PreconditioningStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, James De Lemos, University of Texas Southwestern Medical Center
- Investigators
- James de Lemos, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743937
- Sponsor's protocol ID
- AZUTSW
- Acronym
- ETCH
- Status last verified
- Nov 2020
- First submitted
- 3 Dec 2012
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open Label Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans
- ClinicalTrials.gov ID
- NCT01743937
- Acronym / sponsor ID
- ETCH / AZUTSW
- Conditions
- Ischemic Preconditioning
- Keywords
- Ischemic preconditioning, Ticagrelor, Antiplatelet therapy, Acute coronary syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated due to budgetary issue
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Active comparator | Procedure: Coronary occlusion with balloon inflationCoronary occlusion with balloon inflation |
| Clopidogrel | Active comparator | Procedure: Coronary occlusion with balloon inflationCoronary occlusion with balloon inflation |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary occlusion with balloon inflation | Procedure or surgery | Clopidogrel, Ticagrelor |
Primary outcome
Degree of ST-segment elevation by intracoronary ECG during coronary balloon inflation
Time frame: 7-12 days after drug randomization
6 secondary outcomes
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
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
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
Results and safety
The study was stopped early (reason given: Sponsor terminated due to budgetary issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
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Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James de Lemos, MD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coronary occlusion with balloon inflation in people with Ischemic Preconditioning, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor terminated due to budgetary issue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of ST-segment elevation by intracoronary ECG during coronary balloon inflation (time frame: 7-12 days after drug randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.