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Clopidogrel Resistance and Embolism in Carotid Artery Stenting

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carotid Stenosis

Intervention: Ticlopidine + Ginko biloba (Drug); Clopidogrel (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Oh Young Bang, MD, Principal Investigator, Affiliation: Samsung Medical Center

Overall contact:
Oh Young Bang, MD, Phone: 82-2-3410-3599, Email: neuroboy50@naver.com

Summary

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.

Clinical Details

Official title: Ticlopidine+Ginkgo Biloba Versus Clopidogrel in Clopidogrel Resistant Patients Undergoing Cartoid Artery Stent Placement

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Number and Volume of new ischemic lesions on DWI

Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD)

Ischemic stroke or transient ischemic attack (TIA)

Change of clopidogrel resistance

Pucture site hematoma

Mycocardial infarction

Death

Hematological abnormalities

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Oh Young Bang, MD, Phone: 82-2-3410-3599, Email: neuroboy50@naver.com

Oh Young Bang, Seoul 135710, Korea, Republic of; Recruiting
Oh Young Bang, MD, Phone: 82-2-3410-3599, Email: neuroboy@unitel.co.kr
Suk Jae Kim, MD, Sub-Investigator
Oh Young Bang, MD, Principal Investigator
Mi-Ji Lee, MD, Sub-Investigator
Additional Information

Starting date: June 2014
Last updated: June 28, 2014

Page last updated: August 23, 2015

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