Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation

Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation: Serial FDG PET/CT Imaging Study of Carotid Artery and Ascending Aorta

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01905566

Enrollment

Registered

2013-07-23

Start date

2013-09-30

Completion date

2015-08-31

Last updated

2016-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque, Atherosclerotic

Keywords

Plaque, Atherosclerotic, clopidogrel, ticagrelor, Fluorodeoxyglucose F18, Positron-Emission Tomography and Computed Tomography

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.

Interventions

DRUGClopidogrel

75mg once a day

DRUGTicagrelor

90mg twice a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Serial changes of high-sensitivity C-reactive protein	6months	—
Serial changes of lipid battery	6months	lipid battery (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026