Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Plaque, Atherosclerotic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clopidogrel

clopidogrel: 75mg once a day

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

75mg once a day

Ticagrelor

ticagrelor: 90mg twice a day

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

90mg twice a day

Interventions

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Clopidogrel

75mg once a day

Intervention Type DRUG

Ticagrelor

90mg twice a day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No