Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation

Phase 4

Completed

• Conditions: Plaque, Atherosclerotic
• Interventions: Drug: Clopidogrel; Drug: Ticagrelor

• Registration Number: NCT01905566
• Lead Sponsor: CHEOL WHAN LEE, M.D., Ph.D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-23
• Study Start: 2013-09
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel	Clopidogrel	clopidogrel: 75mg once a day
Ticagrelor	Ticagrelor	ticagrelor: 90mg twice a day

Primary Outcome Measures

Name	Time	Method
change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest	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 Outcome Measures

Name	Time	Method
Serial changes of high-sensitivity C-reactive protein	6months
Serial changes of lipid battery	6months	lipid battery (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol).

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of