Clopidogrel Resistance and Embolism in Carotid Artery Stenting

NCT ID: NCT02133989

Last Updated: 2017-04-26

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carotid Stenosis

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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Ticlopidine+Ginko biloba

Switch to ticlopidine + ginko biloba

Group Type EXPERIMENTAL

Ticlopidine + Ginko biloba

Intervention Type DRUG

ticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily

Clopidogrel

Keep clopidogrel

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

clopidogrel bisulfate 97.875mg(75mg as clopidogrel)

Interventions

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Ticlopidine + Ginko biloba

ticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily

Intervention Type DRUG

Clopidogrel

clopidogrel bisulfate 97.875mg(75mg as clopidogrel)

Intervention Type DRUG

Other Intervention Names

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Yuclid Plavix

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuyu Pharma, Inc.

INDUSTRY

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Oh Young Bang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oh Young Bang, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Oh Young Bang

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Oh Young Bang, MD

Role: CONTACT

82-2-3410-3599

Suk Jae Kim, MD

Role: CONTACT

82-2-3410-1895

Facility Contacts

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Oh Young Bang, MD

Role: primary

82-2-3410-3599

References

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Chung JW, Kim SJ, Hwang J, Lee MJ, Lee J, Lee KY, Park MS, Sung SM, Kim KH, Jeon P, Bang OY. Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting. Front Neurol. 2019 Jan 30;10:44. doi: 10.3389/fneur.2019.00044. eCollection 2019.

Reference Type DERIVED
PMID: 30761076 (View on PubMed)

Other Identifiers

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2013-06-123

Identifier Type: -

Identifier Source: org_study_id

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