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Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation

Primary Purpose

Plaque, Atherosclerotic

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Clopidogrel

Ticagrelor

About this trial

This is an interventional treatment trial for Plaque, Atherosclerotic focused on measuring Plaque, Atherosclerotic, clopidogrel, ticagrelor, Fluorodeoxyglucose F18, Positron-Emission Tomography and Computed Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clopidogrel

Ticagrelor

Arm Description

clopidogrel: 75mg once a day

ticagrelor: 90mg twice a day

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Serial changes of high-sensitivity C-reactive protein

Serial changes of lipid battery

lipid battery (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol).

Full Information

NCT ID

NCT01905566

First Posted

July 19, 2013

Last Updated

February 25, 2016

Sponsor

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

Collaborators

AstraZeneca, CardioVascular Research Foundation, Korea

1. Study Identification

Unique Protocol Identification Number

NCT01905566

Brief Title

Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation

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 Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

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

Collaborators

AstraZeneca, CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque, Atherosclerotic

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clopidogrel

Arm Type

Active Comparator

Arm Description

clopidogrel: 75mg once a day

Arm Title

Ticagrelor

Arm Type

Experimental

Arm Description

ticagrelor: 90mg twice a day

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Intervention Description

75mg once a day

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Intervention Description

90mg twice a day

Primary Outcome Measure Information:

Title

change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest

Description

Time Frame

6months

Secondary Outcome Measure Information:

Title

Serial changes of high-sensitivity C-reactive protein

Time Frame

6months

Title

Serial changes of lipid battery

Description

lipid battery (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol).

Time Frame

6months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cheol-whan Lee, MD, PhD

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

12. IPD Sharing Statement

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Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation

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