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CompletedNCT01905566Updated Feb 26, 2016

Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation

A Phase 4 interventional study of Clopidogrel and Ticagrelor in Plaque, Atherosclerotic, sponsored by CHEOL WHAN LEE, M.D., Ph.D. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-26.

Sponsored by CHEOL WHAN LEE, M.D., Ph.D · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Plaque, Atherosclerotic

Keywords

  • Plaque, Atherosclerotic
  • clopidogrel
  • ticagrelor
  • Fluorodeoxyglucose F18
  • Positron-Emission Tomography and Computed Tomography
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 50 is close to the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

CHEOL WHAN LEE, M.D., Ph.D is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Clopidogrel

    clopidogrel: 75mg once a day

    Drug: Clopidogrel

  • Experimental
    Ticagrelor

    ticagrelor: 90mg twice a day

    Drug: Ticagrelor

Interventions

  • DrugClopidogrel

    75mg once a day

  • DrugTicagrelor

    90mg twice a day

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6months

Secondary outcomes

  1. Serial changes of high-sensitivity C-reactive protein

    Time frame: 6months

  2. Serial changes of lipid battery

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

    Time frame: 6months

07

Study locations

1 site
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01905566
Lead sponsor
CHEOL WHAN LEE, M.D., Ph.D
Collaborators
AstraZeneca, CardioVascular Research Foundation, Korea
Responsible party
CHEOL WHAN LEE, M.D., Ph.D (MD, Asan Medical Center) — Sponsor-investigator
First posted
Jul 23, 2013
Start date
Sep 2013
Primary completion
Jul 2015
Completion
Aug 2015
Last update
Feb 26, 2016

Study contacts

Cheol-whan Lee, MD, PhD
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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