Clopidogrel Resistance and Embolism in Carotid Artery Stenting "CRECAS"

Recruiting

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: clopidogrel bisulfate 97.875mg(75mg as clopidogrel)
    ARM 1: Kind: Experimental
    Label: Clopidogrel
    Description: Keep clopidogrel
  • Ticlopidine + Ginko biloba Drug
    Other Names: Yuclid
    Intervention Desc: ticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily
    ARM 1: Kind: Experimental
    Label: Ticlopidine+Ginko biloba
    Description: Switch to ticlopidine + ginko biloba

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary New ischemic lesion on diffusion-weighted imaging (DWI) within 24 hours after carotid stenting No
Secondary Number and Volume of new ischemic lesions on DWI within 24 hours after carotid stenting No
Secondary Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD) within 24 hours after carotid stenting No
Secondary Ischemic stroke or transient ischemic attack (TIA) within 30 days after carotid stenting No
Secondary Change of clopidogrel resistance 1 day after carotid stenting No
Secondary Pucture site hematoma within 30 days after carotid stenting Yes
Secondary Mycocardial infarction within 30 days after carotid stenting Yes
Secondary Death within 30 days after carotid stenting Yes
Secondary Hematological abnormalities within 30 days after carotid stenting Yes

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