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Carotid Stenosis | Clopidogrel Resistance and Embolism in Carotid Artery Stenting

Carotid Stenosis research study

What is the primary objective of this study?

The purpose of this study is to evaluate the efficacy and safety of the ticlopidine + ginko biloba compared to clopidogrel in clopidogrel resistant patients undergoing carotid artery stent placement. The investigators hypothesized that ticlopidine + ginko biloba is superior than clopidogrel in terms of post-stent ischemic lesions in these patients without serious complications.

Who is eligible to participate?

Inclusion Criteria: - Patients scheduled for stent implantation due to carotid stenosis - Patients resistant to clopidogrel defined by platelet inhibition rate <20% measured by Verify Now before carotid stenting - Patients with informed consent Exclusion Criteria: - Antiplatelet therapy other than aspirin, clopidogrel, or ticlopidine - Unable to perform MRI scans - Patients with hematologic abnormalities including neutrophil <1500/ul, platelet <100,000/uL, or AST/ALT >120 U/L - Unsuitable for participation

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Carotid Stenosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Ticlopidine + Ginko bilobaticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily

Drug:Clopidogrelclopidogrel bisulfate 97.875mg(75mg as clopidogrel)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ticlopidine+Ginko bilobaSwitch to ticlopidine + ginko biloba

ClopidogrelKeep clopidogrel

Study Status

Recruiting

Start Date: June 2014

Completed Date: December 2017

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: New ischemic lesion on diffusion-weighted imaging (DWI)

Secondary Outcome: Number and Volume of new ischemic lesions on DWI

Study sponsors, principal investigator, and references

Principal Investigator: Oh Young Bang, MD

Lead Sponsor: Samsung Medical Center

Collaborator: Yuyu Pharma, Inc.

More information:https://clinicaltrials.gov/show/NCT02133989

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