NCT02133989

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

3.5 years

First QC Date

April 28, 2014

Last Update Submit

April 24, 2017

Conditions

Carotid Stenosis

Keywords

Carotid stenosisStentingClopidogrel resistanceStroke, ischemic

Outcome Measures

Primary Outcomes (1)

  • New ischemic lesion on diffusion-weighted imaging (DWI)

    Presence of new ischemic lesion in the ipsilesioinal hemisphere on DWI after carotid stening

    within 24 hours after carotid stenting

Secondary Outcomes (8)

  • Number and Volume of new ischemic lesions on DWI

    within 24 hours after carotid stenting

  • Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD)

    within 24 hours after carotid stenting

  • Ischemic stroke or transient ischemic attack (TIA)

    within 30 days after carotid stenting

  • Change of clopidogrel resistance

    1 day after carotid stenting

  • Pucture site hematoma

    within 30 days after carotid stenting

  • +3 more secondary outcomes

Study Arms (2)

Ticlopidine+Ginko biloba

EXPERIMENTAL

Switch to ticlopidine + ginko biloba

Drug: Ticlopidine + Ginko biloba

Clopidogrel

ACTIVE COMPARATOR

Keep clopidogrel

Drug: Clopidogrel

Interventions

Ticlopidine + Ginko bilobaDRUG

ticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily

Also known as: Yuclid
Ticlopidine+Ginko biloba
ClopidogrelDRUG

clopidogrel bisulfate 97.875mg(75mg as clopidogrel)

Also known as: Plavix
Clopidogrel

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oh Young Bang

Seoul, 135710, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30761076DERIVED

MeSH Terms

Conditions

Carotid StenosisIschemic Stroke

Interventions

TiclopidineClopidogrel

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesStroke

Intervention Hierarchy (Ancestors)

ThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Oh Young Bang, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oh Young Bang, MD

CONTACT

82-2-3410-3599neuroboy50@naver.com

Suk Jae Kim, MD

CONTACT

82-2-3410-1895sukjae.kim@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 8, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

KR(1)