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 DWIBenign 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
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