Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation: Serial FDG PET/CT Imaging Study of Carotid Artery and Ascending Aorta
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Clopidogrel
clopidogrel: 75mg once a day
Intervention: Clopidogrel (Drug)
Ticagrelor
ticagrelor: 90mg twice a day
Intervention: Ticagrelor (Drug)
Outcomes
Primary Outcomes
change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest
Time Frame: 6months
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).
Secondary Outcomes
- Serial changes of high-sensitivity C-reactive protein(6months)
- Serial changes of lipid battery(6months)
Investigators
CHEOL WHAN LEE, M.D., Ph.D
MD
Asan Medical Center