Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation
Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Plaque, Atherosclerotic
Intervention: Clopidogrel (Drug); Ticagrelor (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: CHEOL WHAN LEE, M.D., Ph.D Official(s) and/or principal investigator(s): Cheol-whan Lee, MD, PhD, Principal Investigator, Affiliation: Asan Medical Center
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.
Clinical Details
Official title: Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation: Serial FDG PET/CT Imaging Study of Carotid Artery and Ascending Aorta
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest
Secondary outcome: Serial changes of high-sensitivity C-reactive proteinSerial changes of lipid battery
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Asan Medical Center, Seoul 138-736, Korea, Republic of
Additional Information
Starting date: September 2013
Last updated: February 13, 2015
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