Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During PCI: an OCT Study
NCT ID: NCT01826175
Last Updated: 2016-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2013-05-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Ticagrelor
Subjects receive 180 mg of ticagrelor immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.
Ticagrelor
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Optical Coherence Tomography
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Clopidogrel
Subjects receive 600 mg of clopidogrel immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.
Clopidogrel
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Optical Coherence Tomography
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Interventions
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Ticagrelor
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Clopidogrel
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Optical Coherence Tomography
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
11. History of TIA or stroke \< 6 months
12. History of hemorrhagic stroke
13. Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia.
1. Lesion located in the left main coronary artery
2. Lesions that are heavily calcified
3. Lesions where OCT cannot be performed due to technical difficulties
4. Other lesions that the investigator deems inappropriate for the procedure such as sites with excessive tortuosity or low flow by TIMI grade.
5. Lesion in saphenous vein or arterial conduit
18 Years
79 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Ik-Kyung Jang, MD, PhD
Professor of Medicine
Principal Investigators
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Ik-Kyung Jang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2013P000225
Identifier Type: -
Identifier Source: org_study_id