Clopidogrel Resistance and Embolism in Carotid Artery Stenting

Phase 3

• Conditions: Carotid Stenosis
• Interventions: Drug: Ticlopidine + Ginko biloba; Drug: Clopidogrel

• Registration Number: NCT02133989
• Lead Sponsor: Samsung Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-08
• Study Start: 2014-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticlopidine+Ginko biloba	Ticlopidine + Ginko biloba	Switch to ticlopidine + ginko biloba
Clopidogrel	Clopidogrel	Keep clopidogrel

Primary Outcome Measures

Name	Time	Method
New ischemic lesion on diffusion-weighted imaging (DWI)	within 24 hours after carotid stenting	Presence of new ischemic lesion in the ipsilesioinal hemisphere on DWI after carotid stening

Secondary Outcome Measures

Name	Time	Method
Number and Volume of new ischemic lesions on DWI	within 24 hours after carotid stenting
Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD)	within 24 hours after carotid stenting
Ischemic stroke or transient ischemic attack (TIA)	within 30 days after carotid stenting
Change of clopidogrel resistance	1 day after carotid stenting	Change of clopidogrel resistance measured by Verify now (P2Y12)
Pucture site hematoma	within 30 days after carotid stenting
Mycocardial infarction	within 30 days after carotid stenting
Death	within 30 days after carotid stenting
Hematological abnormalities	within 30 days after carotid stenting	Neutrophil \<1500/uL Platelet \<100,000/uL AST or ALT \>120 U/L

Trial Locations

Locations (1)

Oh Young Bang; 🇰🇷 Seoul, Korea, Republic of