Clopidogrel Resistance and Embolism in Carotid Artery Stenting (CRECAS)

April 24, 2017 updated by: Oh Young Bang, Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135710
        • Recruiting
        • Oh Young Bang
        • Contact:
        • Sub-Investigator:
          • Mi-Ji Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Yuclid
Active Comparator: Clopidogrel
Keep clopidogrel
Drug: Clopidogrel
clopidogrel bisulfate 97.875mg(75mg as clopidogrel)
Other Names:
  • Plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 24 hours after carotid stenting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Volume of new ischemic lesions on DWI
Time Frame: within 24 hours after carotid stenting
within 24 hours after carotid stenting
Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD)
Time Frame: within 24 hours after carotid stenting
within 24 hours after carotid stenting
Ischemic stroke or transient ischemic attack (TIA)
Time Frame: within 30 days after carotid stenting
within 30 days after carotid stenting
Change of clopidogrel resistance
Time Frame: 1 day after carotid stenting
Change of clopidogrel resistance measured by Verify now (P2Y12)
1 day after carotid stenting
Pucture site hematoma
Time Frame: within 30 days after carotid stenting
within 30 days after carotid stenting
Mycocardial infarction
Time Frame: within 30 days after carotid stenting
within 30 days after carotid stenting
Death
Time Frame: within 30 days after carotid stenting
within 30 days after carotid stenting
Hematological abnormalities
Time Frame: within 30 days after carotid stenting
Neutrophil <1500/uL Platelet <100,000/uL AST or ALT >120 U/L
within 30 days after carotid stenting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Yuyu Pharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 8, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-06-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carotid Stenosis

Clinical Trials on Ticlopidine + Ginko biloba

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe