Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01905566|
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : February 26, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Plaque, Atherosclerotic||Drug: Clopidogrel Drug: Ticagrelor||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||August 2015|
Active Comparator: Clopidogrel
clopidogrel: 75mg once a day
75mg once a day
ticagrelor: 90mg twice a day
90mg twice a day
- change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest [ Time Frame: 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).
- Serial changes of high-sensitivity C-reactive protein [ Time Frame: 6months ]
- Serial changes of lipid battery [ Time Frame: 6months ]lipid battery (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905566
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Cheol-whan Lee, MD, PhD||Asan Medical Center|