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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
Sponsor:
Collaborators:
AstraZeneca
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center

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.


Condition or disease Intervention/treatment Phase
Plaque, Atherosclerotic Drug: Clopidogrel Drug: Ticagrelor Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clopidogrel
clopidogrel: 75mg once a day
Drug: Clopidogrel
75mg once a day

Experimental: Ticagrelor
ticagrelor: 90mg twice a day
Drug: Ticagrelor
90mg twice a day




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Serial changes of high-sensitivity C-reactive protein [ Time Frame: 6months ]
  2. Serial changes of lipid battery [ Time Frame: 6months ]
    lipid battery (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
CHEOL WHAN LEE, M.D., Ph.D
AstraZeneca
CardioVascular Research Foundation, Korea
Investigators
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Principal Investigator: Cheol-whan Lee, MD, PhD Asan Medical Center
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Responsible Party: CHEOL WHAN LEE, M.D., Ph.D, MD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01905566    
Other Study ID Numbers: AMCCV2012-02
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016
Keywords provided by CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center:
Plaque, Atherosclerotic
clopidogrel
ticagrelor
Fluorodeoxyglucose F18
Positron-Emission Tomography and Computed Tomography
Additional relevant MeSH terms:
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Inflammation
Plaque, Atherosclerotic
Pathologic Processes
Pathological Conditions, Anatomical
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs