Clopidogrel Resistance and Embolism in Carotid Artery Stenting

Carotid Stenosis Clinical Trial

— CRECAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02133989
• Other study ID #: 2013-06-123
• Status: Recruiting
• Phase: Phase 3
• First received: April 28, 2014
• Last updated: April 24, 2017
• Start date: June 2014
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Samsung Medical Center
• Contact: Oh Young Bang, MD
• Phone: 82-2-3410-3599
• Email: neuroboy50[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Drug:
• Ticlopidine + Ginko biloba
ticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily
• Clopidogrel
clopidogrel bisulfate 97.875mg(75mg as clopidogrel)

Locations

Country	Name	City	State
Korea, Republic of	Oh Young Bang	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Yuyu Pharma, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New ischemic lesion on diffusion-weighted imaging (DWI)	Presence of new ischemic lesion in the ipsilesioinal hemisphere on DWI after carotid stening	within 24 hours after carotid stenting
Secondary	Number and Volume of new ischemic lesions on DWI		within 24 hours after carotid stenting
Secondary	Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD)		within 24 hours after carotid stenting
Secondary	Ischemic stroke or transient ischemic attack (TIA)		within 30 days after carotid stenting
Secondary	Change of clopidogrel resistance	Change of clopidogrel resistance measured by Verify now (P2Y12)	1 day after carotid stenting
Secondary	Pucture site hematoma		within 30 days after carotid stenting
Secondary	Mycocardial infarction		within 30 days after carotid stenting
Secondary	Death		within 30 days after carotid stenting
Secondary	Hematological abnormalities	Neutrophil <1500/uL Platelet <100,000/uL AST or ALT >120 U/L	within 30 days after carotid stenting