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Clopidogrel Resistance and Embolism in Carotid Artery Stenting (CRECAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02133989
Recruitment Status : Unknown
Verified April 2017 by Oh Young Bang, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : May 8, 2014
Last Update Posted : April 26, 2017
Yuyu Pharma, Inc.
Information provided by (Responsible Party):
Oh Young Bang, 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.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Drug: Ticlopidine + Ginko biloba Drug: Clopidogrel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ticlopidine+Ginkgo Biloba Versus Clopidogrel in Clopidogrel Resistant Patients Undergoing Cartoid Artery Stent Placement
Study Start Date : June 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Ticlopidine+Ginko biloba
Switch to ticlopidine + ginko biloba
Drug: Ticlopidine + Ginko biloba
ticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily
Other Name: Yuclid

Active Comparator: Clopidogrel
Keep clopidogrel
Drug: Clopidogrel
clopidogrel bisulfate 97.875mg(75mg as clopidogrel)
Other Name: Plavix

Primary Outcome Measures :
  1. New ischemic lesion on diffusion-weighted imaging (DWI) [ Time Frame: within 24 hours after carotid stenting ]
    Presence of new ischemic lesion in the ipsilesioinal hemisphere on DWI after carotid stening

Secondary Outcome Measures :
  1. Number and Volume of new ischemic lesions on DWI [ Time Frame: within 24 hours after carotid stenting ]
  2. Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD) [ Time Frame: within 24 hours after carotid stenting ]
  3. Ischemic stroke or transient ischemic attack (TIA) [ Time Frame: within 30 days after carotid stenting ]
  4. Change of clopidogrel resistance [ Time Frame: 1 day after carotid stenting ]
    Change of clopidogrel resistance measured by Verify now (P2Y12)

  5. Pucture site hematoma [ Time Frame: within 30 days after carotid stenting ]
  6. Mycocardial infarction [ Time Frame: within 30 days after carotid stenting ]
  7. Death [ Time Frame: within 30 days after carotid stenting ]
  8. Hematological abnormalities [ Time Frame: within 30 days after carotid stenting ]
    Neutrophil <1500/uL Platelet <100,000/uL AST or ALT >120 U/L

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02133989

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Contact: Oh Young Bang, MD 82-2-3410-3599
Contact: Suk Jae Kim, MD 82-2-3410-1895

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Korea, Republic of
Oh Young Bang Recruiting
Seoul, Korea, Republic of, 135710
Contact: Oh Young Bang, MD    82-2-3410-3599   
Sub-Investigator: Suk Jae Kim, MD         
Principal Investigator: Oh Young Bang, MD         
Sub-Investigator: Mi-Ji Lee, MD         
Sponsors and Collaborators
Samsung Medical Center
Yuyu Pharma, Inc.
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Principal Investigator: Oh Young Bang, MD Samsung Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Oh Young Bang, MD, Samsung Medical Center Identifier: NCT02133989    
Other Study ID Numbers: 2013-06-123
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Keywords provided by Oh Young Bang, Samsung Medical Center:
Carotid stenosis
Clopidogrel resistance
Stroke, ischemic
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors