Effect of Pretreatment With Ticagrelor on Residual Thrombus After PCI in Patients Presenting With ACS in Comparison With Delayed Treatment at the Time of PCI: an OCT Study



Status:Not yet recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 79
Updated:5/5/2014
Start Date:January 2014
Contact:Shankha Mukhopadhyay, MS
Email:smukhopadhyay2@partners.org
Phone:617 726 2612

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Effect of Pretreatment With Ticagrelor on Residual Thrombus After Percutaneous Coronary Intervention (PCI) in Patients Presenting With Acute Coronary Syndrome in Comparison With Delayed Treatment at the Time of PCI: an Optical Coherence Tomography Study

Subjects presenting with probable acute coronary syndromes scheduled for cardiac
catheterization will be enrolled in this study. Consented subjects will be randomized to
receive ticagrelor started with a loading dose immediately after enrollment versus receiving
a loading dose of ticagrelor during cardiac catheterization after diagnostic angiography but
prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and
the volume of thrombus within the new stent will be measured and compared between the
groups.


Inclusion Criteria:

Patient Characteristics:

1. Males and non-pregnant females > or equal to 18 and < or equal to 79 years of age
presenting with suspected acute coronary syndrome (unstable angina or NSTEMI)

2. Patients likely to be 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:

Patient Specific 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 eGFR < 60 ml/min/1.73m2.

11. Subjects currently taking oral anticoagulants with an absolute contraindication to
discontinuation of anticoagulation.

12. History of TIA or stroke < 6 months.

13. History of hemorrhagic stroke.

14. Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase
greater than 3 times the upper limit of normal or hyperbilirubinemia.

15. Cardiac catheterization scheduled within 4 hours of randomization or more then 72
hours after randomization.

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

1. Lesions 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. Lesions in saphenous vein grafts or arterial conduits.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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