Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation

CHEOL WHAN LEE, M.D., Ph.D

Status and phase

Completed

Phase 4

Conditions

Plaque, Atherosclerotic

Treatments

Drug: Ticagrelor

Drug: Clopidogrel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01905566

AMCCV2012-02

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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