Clopidogrel Resistance and Embolism in Carotid Artery Stenting (CRECAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Samsung Medical Center
Sponsor:
Collaborator:
Yuyu Pharma, Inc.
Information provided by (Responsible Party):
Oh Young Bang, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02133989
First received: April 28, 2014
Last updated: June 28, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Carotid Stenosis
Drug: Ticlopidine + Ginko biloba
Drug: Clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ticlopidine+Ginkgo Biloba Versus Clopidogrel in Clopidogrel Resistant Patients Undergoing Cartoid Artery Stent Placement

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • New ischemic lesion on diffusion-weighted imaging (DWI) [ Time Frame: within 24 hours after carotid stenting ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 24 hours after carotid stenting ] [ Designated as safety issue: No ]
  • Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD) [ Time Frame: within 24 hours after carotid stenting ] [ Designated as safety issue: No ]
  • Ischemic stroke or transient ischemic attack (TIA) [ Time Frame: within 30 days after carotid stenting ] [ Designated as safety issue: No ]
  • Change of clopidogrel resistance [ Time Frame: 1 day after carotid stenting ] [ Designated as safety issue: No ]
    Change of clopidogrel resistance measured by Verify now (P2Y12)

  • Pucture site hematoma [ Time Frame: within 30 days after carotid stenting ] [ Designated as safety issue: Yes ]
  • Mycocardial infarction [ Time Frame: within 30 days after carotid stenting ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: within 30 days after carotid stenting ] [ Designated as safety issue: Yes ]
  • Hematological abnormalities [ Time Frame: within 30 days after carotid stenting ] [ Designated as safety issue: Yes ]
    Neutrophil <1500/uL Platelet <100,000/uL AST or ALT >120 U/L


Estimated Enrollment: 86
Study Start Date: June 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02133989

Contacts
Contact: Oh Young Bang, MD 82-2-3410-3599 neuroboy50@naver.com
Contact: Suk Jae Kim, MD 82-2-3410-1895 sukjae.kim@gmail.com

Locations
Korea, Republic of
Oh Young Bang Recruiting
Seoul, Korea, Republic of, 135710
Contact: Oh Young Bang, MD    82-2-3410-3599    neuroboy@unitel.co.kr   
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.
Investigators
Principal Investigator: Oh Young Bang, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Oh Young Bang, MD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02133989     History of Changes
Other Study ID Numbers: 2013-06-123
Study First Received: April 28, 2014
Last Updated: June 28, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Carotid stenosis
Stenting
Clopidogrel resistance
Stroke, ischemic

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014