MedDataX Logo

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

NCT ID: NCT01743937

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Preconditioning

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ischemic preconditioning Ticagrelor Antiplatelet therapy Acute coronary syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ticagrelor

Coronary occlusion with balloon inflation

Group Type ACTIVE_COMPARATOR

Coronary occlusion with balloon inflation

Intervention Type PROCEDURE

Clopidogrel

Coronary occlusion with balloon inflation

Group Type ACTIVE_COMPARATOR

Coronary occlusion with balloon inflation

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coronary occlusion with balloon inflation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James De Lemos

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James de Lemos, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dallas Veterans Affairs Medical Center

Dallas, Texas, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AZUTSW

Identifier Type: -

Identifier Source: org_study_id