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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


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 protein

Serial changes of lipid battery


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Men or Women at least 18 years of age inclusive

- Patients with acute coronary syndromes (unstable angina pectoris Braunwald class IB,


- 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

Page last updated: August 23, 2015

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