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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01826175

Collaborator

AstraZeneca (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Coronary Artery Disease	Drug: Ticagrelor Drug: Clopidogrel Device: Optical Coherence Tomography	Phase 4

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ticagrelor Subjects receive 180 mg of ticagrelor immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.	Drug: 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. Other Names: Brilinta Brilique Possia Device: 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 Names: OCT
Active Comparator: Clopidogrel Subjects receive 600 mg of clopidogrel immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.	Drug: 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. Other Names: Plavix Device: 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 Names: OCT

Arm

Intervention/Treatment

Experimental: Ticagrelor

Subjects receive 180 mg of ticagrelor immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.

Drug: 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.

Other Names:

Brilinta

Brilique

Possia

Device: 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 Names:

OCT

Active Comparator: Clopidogrel

Subjects receive 600 mg of clopidogrel immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.

Drug: 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.

Other Names:

Plavix

Device: 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 Names:

OCT

Outcome Measures

Primary Outcome Measures

Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry. [Thrombus burden will be measured at the end of the coronary artery stenting procedure.]
The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry.

Secondary Outcome Measures

PRI (platelet reactivity index) as measured by the PLT-VASP assay. [PRI will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).]
The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay. [P2Y12 will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).]
The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.

Other Outcome Measures

PCI- related myocardial infarction (MI) [PCI-related MI will be assessed within 24 hours after the end of the coronary artery stenting procedure.]
PCI related myocardial infarction is defined by the third Universal defintion of myocardial infarction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient Characteristics:

Males and non-pregnant females > 18 and < 79 years of age presenting with acute coronary syndrome defined as having two of the following criteria:
Signs and symptoms consistent with accelerated angina or prolonged angina (lasting greater than 20 minutes) either at rest or with minimal exertion
ECG changes indicative of new ischemia
Levels of cardiac biomarkers (troponin-T) above the upper limit of the normal range.
Patients scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)

Lesion Characteristics on Diagnostic Coronary Angiography

De novo lesions in native coronary arteries found by diagnostic coronary angiography
Angiographic stenosis <100%
Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation

Exclusion Criteria:

General Exclusion Criteria

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

Lesion located in the left main coronary artery
Lesions that are heavily calcified
Lesions where OCT cannot be performed due to technical difficulties
Other lesions that the investigator deems inappropriate for the procedure such as sites with excessive tortuosity or low flow by TIMI grade.
Lesion in saphenous vein or arterial conduit