Clopidogrel Resistance and Embolism in Carotid Artery Stenting (CRECAS)

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Carotid Stenosis

Treatments: Drug: Clopidogrel; Drug: Ticlopidine + Ginko biloba

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02133989

2013-06-123

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Ticlopidine+Ginko biloba

Experimental group

Description:

Switch to ticlopidine + ginko biloba

Treatment:

Drug: Ticlopidine + Ginko biloba

Clopidogrel

Active Comparator group

Description:

Keep clopidogrel

Treatment:

Drug: Clopidogrel