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Clopidogrel Resistance and Embolism in Carotid Artery Stenting (CRECAS)

Primary Purpose

Carotid Stenosis

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ticlopidine + Ginko biloba
Clopidogrel
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Stenosis focused on measuring Carotid stenosis, Stenting, Clopidogrel resistance, Stroke, ischemic

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Oh Young BangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticlopidine+Ginko biloba

Clopidogrel

Arm Description

Switch to ticlopidine + ginko biloba

Keep clopidogrel

Outcomes

Primary Outcome Measures

New ischemic lesion on diffusion-weighted imaging (DWI)
Presence of new ischemic lesion in the ipsilesioinal hemisphere on DWI after carotid stening

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2014
Last Updated
April 24, 2017
Sponsor
Samsung Medical Center
Collaborators
Yuyu Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02133989
Brief Title
Clopidogrel Resistance and Embolism in Carotid Artery Stenting
Acronym
CRECAS
Official Title
Ticlopidine+Ginkgo Biloba Versus Clopidogrel in Clopidogrel Resistant Patients Undergoing Cartoid Artery Stent Placement
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Yuyu Pharma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis
Keywords
Carotid stenosis, Stenting, Clopidogrel resistance, Stroke, ischemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ticlopidine+Ginko biloba
Arm Type
Experimental
Arm Description
Switch to ticlopidine + ginko biloba
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Keep clopidogrel
Intervention Type
Drug
Intervention Name(s)
Ticlopidine + Ginko biloba
Other Intervention Name(s)
Yuclid
Intervention Description
ticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
clopidogrel bisulfate 97.875mg(75mg as clopidogrel)
Primary Outcome Measure Information:
Title
New ischemic lesion on diffusion-weighted imaging (DWI)
Description
Presence of new ischemic lesion in the ipsilesioinal hemisphere on DWI after carotid stening
Time Frame
within 24 hours after carotid stenting
Secondary Outcome Measure Information:
Title
Number and Volume of new ischemic lesions on DWI
Time Frame
within 24 hours after carotid stenting
Title
Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD)
Time Frame
within 24 hours after carotid stenting
Title
Ischemic stroke or transient ischemic attack (TIA)
Time Frame
within 30 days after carotid stenting
Title
Change of clopidogrel resistance
Description
Change of clopidogrel resistance measured by Verify now (P2Y12)
Time Frame
1 day after carotid stenting
Title
Pucture site hematoma
Time Frame
within 30 days after carotid stenting
Title
Mycocardial infarction
Time Frame
within 30 days after carotid stenting
Title
Death
Time Frame
within 30 days after carotid stenting
Title
Hematological abnormalities
Description
Neutrophil <1500/uL Platelet <100,000/uL AST or ALT >120 U/L
Time Frame
within 30 days after carotid stenting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oh Young Bang, MD
Phone
82-2-3410-3599
Email
neuroboy50@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suk Jae Kim, MD
Phone
82-2-3410-1895
Email
sukjae.kim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oh Young Bang, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oh Young Bang
City
Seoul
ZIP/Postal Code
135710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oh Young Bang, MD
Phone
82-2-3410-3599
Email
neuroboy@unitel.co.kr
First Name & Middle Initial & Last Name & Degree
Suk Jae Kim, MD
First Name & Middle Initial & Last Name & Degree
Oh Young Bang, MD
First Name & Middle Initial & Last Name & Degree
Mi-Ji Lee, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30761076
Citation
Chung JW, Kim SJ, Hwang J, Lee MJ, Lee J, Lee KY, Park MS, Sung SM, Kim KH, Jeon P, Bang OY. Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting. Front Neurol. 2019 Jan 30;10:44. doi: 10.3389/fneur.2019.00044. eCollection 2019.
Results Reference
derived

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Clopidogrel Resistance and Embolism in Carotid Artery Stenting

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