Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation

Study Overview
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Brief Summary
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Objectives: To compare the effects of clopidogrel versus ticagrelor on atherosclerotic plaque inflammation using serial FDG PET/CT imaging of carotid artery and ascending aorta. Hypothesis: Thrombosis and inflammation are tightly linked rather than separate entities. Therefore, P2Y12 receptor inhibitors may have an anti-ischemic effect by inhibiting plaque inflammation, and ticagrelor may be superior in efficacy to clopidogrel.

Official Title
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Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation: Serial FDG PET/CT Imaging Study of Carotid Artery and Ascending Aorta

Conditions
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Plaque, Atherosclerotic

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or Women at least 18 years of age inclusive Patients with acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC, NSTEMI or STEMI) FDG PET/CT shows at least 1 hot uptakes at carotid and or ascending aorta The patient or guardian agrees to the study protocol and the schedule of clinical and FDG PET/CT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: Patients treated with carotid endarterectomy or stent placement Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible). Untreated hyperthyroidism, or hypothyroidism Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. Evidence of congestive heart failure, or left ventricular ejection fraction < 40%. Significant renal disease manifested by serum creatinine > 2.0mg/dL, or creatinine clearance of < 40 ml/min (by Cockcroft-Gault method). Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal). History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s). Unwillingness or inability to comply with the procedures described in this protocol. Patient's pregnant or breast-feeding or child-bearing potential. Type I Diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clopidogrel<br>clopidogrel: 75mg once a day | Drug: Clopidogrel<br>* 75mg once a day<br>|
| Experimental: Ticagrelor<br>ticagrelor: 90mg twice a day | Drug: Ticagrelor<br>* 90mg twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest | Analyses of FDG activity will be quantified on common carotid arteries and ascending aorta of the aortic arch. Primary endpoint is change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest, known as a target-to-background ratio(blood-normalized standardized uptake value). | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serial changes of high-sensitivity C-reactive protein |  | 6months | 
| Serial changes of lipid battery | lipid battery (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol). | 6months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque, Atherosclerotic, clopidogrel, ticagrelor, Fluorodeoxyglucose F18, Positron-Emission Tomography and Computed Tomography