Carotid StenosisPhase 3CRECASNCT02133989
Clopidogrel Resistance and Embolism in Carotid Artery Stenting
A Phase 3 study testing Ticlopidine + Ginko biloba and Clopidogrel in people with Carotid Stenosis, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Ticlopidine + Ginko biloba and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Oh Young Bang
Seoul, 135710
Oh Young Bang, MD, 82-2-3410-3599, neuroboy@unitel.co.kr
Suk Jae Kim, MD
About this study
Official title: 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.
- Conditions
- Carotid Stenosis
- Being tested
- Ticlopidine + Ginko biloba, Clopidogrel
- Keywords
- Carotid stenosis, Stenting, Clopidogrel resistance, Stroke, ischemic
- Medical subject headings
- Carotid Stenosis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticlopidine + Ginko bilobaDrug
Also called Yuclid
ticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily
ClopidogrelDrug
Also called Plavix
clopidogrel bisulfate 97.875mg(75mg as clopidogrel)
| Study group | Role | What they receive |
|---|---|---|
| Ticlopidine+Ginko biloba | Experimental | Switch to ticlopidine + ginko biloba Receives: Drug: Ticlopidine + Ginko biloba |
| Clopidogrel | Active comparator | Keep clopidogrel Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
New ischemic lesion on diffusion-weighted imaging (DWI)
Presence of new ischemic lesion in the ipsilesioinal hemisphere on DWI after carotid stening
Measured: within 24 hours after carotid stenting
Secondary outcomes (8)
Number and Volume of new ischemic lesions on DWI
Measured: within 24 hours after carotid stenting
Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD)
Measured: within 24 hours after carotid stenting
Ischemic stroke or transient ischemic attack (TIA)
Measured: within 30 days after carotid stenting
Change of clopidogrel resistance
Change of clopidogrel resistance measured by Verify now (P2Y12)
Measured: 1 day after carotid stenting
Pucture site hematoma
Measured: within 30 days after carotid stenting
Mycocardial infarction
Measured: within 30 days after carotid stenting
Death
Measured: within 30 days after carotid stenting
Hematological abnormalities
Neutrophil <1500/uL Platelet <100,000/uL AST or ALT >120 U/L
Measured: within 30 days after carotid stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yuyu Pharma, Inc.
- Responsible party
- Principal investigator, Oh Young Bang, Samsung Medical Center
- Investigators
- Oh Young Bang, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133989
- Sponsor's protocol ID
- 2013-06-123
- Acronym
- CRECAS
- Status last verified
- Apr 2017
- First submitted
- 28 Apr 2014
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30761076
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticlopidine+Ginkgo Biloba Versus Clopidogrel in Clopidogrel Resistant Patients Undergoing Cartoid Artery Stent Placement
- ClinicalTrials.gov ID
- NCT02133989
- Acronym / sponsor ID
- CRECAS / 2013-06-123
- Conditions
- Carotid Stenosis
- Keywords
- Carotid stenosis, Stenting, Clopidogrel resistance, Stroke, ischemic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Yuyu Pharma, Inc.
- Study start
- Jun 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticlopidine+Ginko biloba | Experimental | Drug: Ticlopidine + Ginko bilobaSwitch to ticlopidine + ginko biloba |
| Clopidogrel | Active comparator | Drug: ClopidogrelKeep clopidogrel |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticlopidine + Ginko bilobaAlso: Yuclidticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily | Drug | Ticlopidine+Ginko biloba |
| ClopidogrelAlso: Plavixclopidogrel bisulfate 97.875mg(75mg as clopidogrel) | Drug | Clopidogrel |
Primary outcome
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
8 secondary outcomes
Number and Volume of new ischemic lesions on DWI
Time frame: within 24 hours after carotid stenting
Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD)
Time frame: within 24 hours after carotid stenting
Ischemic stroke or transient ischemic attack (TIA)
Time frame: within 30 days after carotid stenting
Change of clopidogrel resistance
Time frame: 1 day after carotid stenting
Pucture site hematoma
Time frame: within 30 days after carotid stenting
Mycocardial infarction
Time frame: within 30 days after carotid stenting
Death
Time frame: within 30 days after carotid stenting
Hematological abnormalities
Time frame: within 30 days after carotid stenting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Derived from this study: PubMed 30761076Chung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oh Young Bang, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticlopidine + Ginko biloba and Clopidogrel in people with Carotid Stenosis, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oh Young Bang, MD (82-2-3410-3599, neuroboy50@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New ischemic lesion on diffusion-weighted imaging (DWI) (time frame: within 24 hours after carotid stenting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02133989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.