Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation

Plaque, Atherosclerotic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905566
• Other study ID #: AMCCV2012-02
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2013
• Last updated: February 25, 2016
• Start date: September 2013
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque, Atherosclerotic

Intervention

Drug:
• Clopidogrel
75mg once a day
• Ticagrelor
90mg twice a day

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
CHEOL WHAN LEE, M.D., Ph.D	AstraZeneca, CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest	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).	6months	No
Secondary	Serial changes of high-sensitivity C-reactive protein		6months	No
Secondary	Serial changes of lipid battery	lipid battery (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol).	6months	No