NCT01905566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

July 19, 2013

Last Update Submit

February 25, 2016

Conditions

Plaque, Atherosclerotic

Keywords

Plaque, AtheroscleroticclopidogrelticagrelorFluorodeoxyglucose F18Positron-Emission Tomography and Computed Tomography

Outcome Measures

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).

    6months

Secondary Outcomes (2)

  • Serial changes of high-sensitivity C-reactive protein

    6months

  • Serial changes of lipid battery

    6months

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

clopidogrel: 75mg once a day

Drug: Clopidogrel

Ticagrelor

EXPERIMENTAL

ticagrelor: 90mg twice a day

Drug: Ticagrelor

Interventions

ClopidogrelDRUG

75mg once a day

Clopidogrel
TicagrelorDRUG

90mg twice a day

Ticagrelor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Plaque, Atherosclerotic

Interventions

ClopidogrelTicagrelor

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAdenosinePurine NucleosidesPurinesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Cheol-whan Lee, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 23, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

KR(1)