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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndrome; Coronary Artery Disease

Intervention: Ticagrelor (Drug); Clopidogrel (Drug); Optical Coherence Tomography (Device)

Phase: Phase 4

Status: Terminated

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Ik-Kyung Jang, MD, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Primary outcome: Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry.

Secondary outcome:

PRI (platelet reactivity index) as measured by the PLT-VASP assay.

P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay.

Eligibility

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

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: General 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. 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. Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by OCT. 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

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Starting date: May 2013
Last updated: June 27, 2014

Page last updated: August 23, 2015

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