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Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During PCI: an OCT Study | Clinical Trials | Clareo Health

WITHDRAWNPHASE4

Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During PCI: an OCT Study

Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During Percutaneous Coronary Intervention: an Optical Coherence Tomography Study

NCT01826175•Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups.

Detailed Description

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient Characteristics:
•1. Males and non-pregnant females \> 18 and \< 79 years of age presenting with acute coronary syndrome defined as having two of the following criteria:
•1. Signs and symptoms consistent with accelerated angina or prolonged angina (lasting greater than 20 minutes) either at rest or with minimal exertion
•2. ECG changes indicative of new ischemia
•3. Levels of cardiac biomarkers (troponin-T) above the upper limit of the normal range.
•2. Patients scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)
•Lesion Characteristics on Diagnostic Coronary Angiography
•1. De novo lesions in native coronary arteries found by diagnostic coronary angiography
•2. Angiographic stenosis \<100%
•3. Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation

Exclusion Criteria

•1. Subjects who are unable or unwilling to sign the informed consent form
•2. Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
•3. Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study
•4. Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction \< 30%
•5. Subjects with an ST elevation myocardial infarction
•6. Subjects with hemodynamic or electrical instability (including shock)
•7. Subjects diagnosed with severe, non-catheter-related coronary artery spasm
•8. Subjects who are or may be pregnant
•9. Subjects with known allergies to contrast media
•10. Subjects with renal failure as defined by eGFR \< 60.
+8 more criteria

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

May 1, 2013

Primary Completion Date

May 1, 2014

Completion Date

May 1, 2014

Last Updated

December 20, 2016

Conditions

Acute Coronary SyndromeCoronary Artery Disease

Interventions

Ticagrelor

DRUG

Clopidogrel

DRUG

Optical Coherence Tomography

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During PCI: an OCT Study

Inclusion Criteria

Exclusion Criteria

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