Status:
COMPLETED
Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation
Lead Sponsor:
CHEOL WHAN LEE, M.D., Ph.D
Collaborating Sponsors:
AstraZeneca
CardioVascular Research Foundation, Korea
Conditions:
Plaque, Atherosclerotic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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: Thrombosi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01905566
Start Date
September 1 2013
End Date
August 1 2015
Last Update
February 26 2016
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736