In-stent Restenosis After Carotid Artery StentingCAS-CARENCT01261234
Carotid Artery Stenting With Cilostazol Addition for Restenosis
A study testing Cilostazol or Non-Cilostazol in people with In-stent Restenosis After Carotid Artery Stenting, run by Kobe City General Hospital at 1 site in Japan.
Trial summary
CAS-CARE study was conducted to evaluate the inhibitory effect of cilostazol, compared to that of other antiplatelet drugs, on in-stent restenosis following carotid artery stenting (CAS) in patients scheduled to undergo CAS. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- In-stent Restenosis After Carotid Artery Stenting
- What is being tested?
- Cilostazol or Non-Cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 707 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2010to Sep 2019
- Phase
- Interventional
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50% or more symptomatic carotid artery stenosis or 80% or more asymptomatic carotid artery stenosis
- scheduled for carotid artery stenting within 30 days
- 45 or more years-old and less than 80 years old
- antiplatelet agents can be administratered orally
- follow-up is anticipated possible for 2 years after CAS
- self-supporoted in daily activities (modified Rankin Scale 2 or less)
- patients who have given informed consent to participation in the study
Who cannot join
- received endovascular interevention
- scheduled for bilateral carotid intervention
- aortitis or cvasculitis
- congessive heart failure
- ischemic stroke within 48 hours
- hemorrhagic stroke within 90 days
- renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cilostazol on In-stent Restenosis After Carotid Artery Stenting; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial
CAS-CARE study was conducted to evaluate the inhibitory effect of cilostazol, compared to that of other antiplatelet drugs, on in-stent restenosis following carotid artery stenting (CAS) in patients scheduled to undergo CAS. Study design is Multicenter Prospective Ranodomized Controlled Study, rondomized by cilostazol/non-cilostazol group prior to CAS. 900 patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after CAS, evaluated by carotid ultrasound and angiography.
Read the detailed description
Restenosis after carotid artery stenting (CAS) is a critical issue. Cilostazol can reduce restenosis after interventions in coronary or femoropopliteal arteries. The investigators confirmed and published periprocedural cilostazol administration reduced incidences of in-stent restenosis (ISR) or target vessel revascularization (TVR) after CAS, retrospectively.
CAS-CARE study is Multicenter Prospective Ranodomized Controlled Study. Patients, scheduled for CAS within 30 days, 50% or more symptomatic carotid stenosis or 80% or more asymptomatic carotid stenosis, will enroll and randomize by cilostazol/non-cilostazol group. 900 patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after CAS, evaluated by carotid ultrasound and angiography. And, evaluate cardiovascular events, including stroke, myocardial infarction, and hemorrhagic events in periprocedural period and followed period. In this study, ISR is diagnosed by ultrasound and DSA/CTA. Equivalence of CTA to ultrasound will be studied.
- Being tested
- Cilostazol or Non-Cilostazol
- Keywords
- Carotid Artery Disease, Carotid Artery Stenting, In stent restenosis, Cardiovascular event, Intima Media Thickness
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol or Non-CilostazolDrug
Also called Cilostazol (Pretal) group, Non-Cilostazol (Pretal) group
Cilostazol group administrate 100-200mg/day per oral, unrestricted use of other antiplatelet agents and concomitant drugs.
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol group | Experimental | Continuous administration of cilostazol (unrestricted use of other antiplatelet agents and concomitant drugs) Receives: Drug: Cilostazol or Non-Cilostazol |
| Non-Cilostazol group | Active comparator | Antiplatelet agent other than cilostazol (unrestricted use of concomitant drugs) Receives: Drug: Cilostazol or Non-Cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of in-stent restenosis within 2 years after CAS and time to occurrence
Difinition of endpoint is 50% or more in-stent restenosis detected by carotid ultrasound or angiopraphy. In cases restenosis does not occur, the final observation point will be used as the final evaluation point.
Measured: 2 years
Secondary outcomes (7)
Cardiovascular event, death, hemorrhagic event, in-stent restenosis, new out-stent stenosis, or retreatment of stented artery within 2 yrs
Any events, including death, cardiovascular event(stroke, myocardial infarction), hemorrhagic event, in-stent restenosis, new out-stent stenosis, retreatment of stented artery, within 2 years
Measured: 2 years
In-stent restenosis, new out-stent stenosis, or retreatment within 2 years
In-stent restenosis, new out-stent stenosis detected by ultrasound or CTA/DSA, or retreatment of stented artery within 2 years
Measured: 2 years
hemorrhagic event within 2 years
hemorrhagic stroke, major hemorrhage required 2 unit or more transfusion
Measured: 2 years
stroke within 2 years
any ischemic or hemorrhagic stroke
Measured: 2 years
In-stent restenosis, new out-stent stenosis, or retreatment of stented artery, cardiovascular event, or death from any cause within 30 days
Any peri-procedural events; in-stent restenosis, new out-stent stenosis, or retreatment of stented artery, cardiovascular event(stroke, myocardial infarction), or death from any cause
Measured: 30 days
Severe in-stent restenosis within 2 yrs
70% or more in-stent restenosis, diagnosed by ultrasound or DSA/CTA,
Measured: 2 yeras
Change from baseline in max-IMT in both common carotid arteries
Intima-Media thickness of common carotid artery measured by ultrasound
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2019
- Study completionSep 2019
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 In-stent Restenosis After Carotid Artery StentingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 707 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kobe City General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chiba University, Nagoya University, Mie University, Wakayama Medical University, Kyoto University, Osaka University, Kobe University, Foundation for Biomedical Research and Innovation, Okayama University, Yamaguchi University Hospital, Fukuoka University, Nagasaki University
- Responsible party
- Principal investigator, Nobuyuki Sakai, Kobe City General Hospital
- Investigators
- Nobuyuki Sakai, MD, DMSc, Principal investigator, Kobe City Medical Center General HospitalHiroshi Yamagami, MD, PhD, Principal investigator, Kobe City Medical Center General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261234
- Sponsor's protocol ID
- TRIBRAIN1010
- Other IDs
- UMIN000004705
- Acronym
- CAS-CARE
- Status last verified
- Oct 2019
- First submitted
- 11 Dec 2010
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yamagami H, Ozaki T, Ogasawara K, Nagata I, Matsumaru Y, Yoshimura S, Sasaki M, Nagatsuka K, Minematsu K, Nagai Y, Sakai C, Matsumoto Y, Ezura M, Ishihara H, Sakai N; CAS-CARE Investigators. Randomized Controlled Trial of Cilostazol Addition for In-Stent Restenosis After Carotid Artery Stenting. Stroke. 2024 Dec;55(12):2776-2785. doi: 10.1161/STROKEAHA.124.047210. Epub 2024 Nov 25.
PubMed 39585936
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cilostazol on In-stent Restenosis After Carotid Artery Stenting; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial
- ClinicalTrials.gov ID
- NCT01261234
- Acronym / sponsor ID
- CAS-CARE / TRIBRAIN1010
- Keywords
- Carotid Artery Disease, Carotid Artery Stenting, In stent restenosis, Cardiovascular event, Intima Media Thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- Kobe City General HospitalUniversity, hospital or other
- Collaborators
- Chiba University, Nagoya University, Mie University, Wakayama Medical University, Kyoto University, Osaka University, Kobe University, Foundation for Biomedical Research and Innovation, Okayama University, Yamaguchi University Hospital, Fukuoka University, Nagasaki University
- Study start
- Dec 2010 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 16 Dec 2010 (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.
CAS-CARE study was conducted to evaluate the inhibitory effect of cilostazol, compared to that of other antiplatelet drugs, on in-stent restenosis following carotid artery stenting (CAS) in patients scheduled to undergo CAS. Study design is Multicenter Prospective Ranodomized Controlled Study, rondomized by cilostazol/non-cilostazol group prior to CAS. 900 patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after CAS, evaluated by carotid ultrasound and angiography.
Detailed description
Restenosis after carotid artery stenting (CAS) is a critical issue. Cilostazol can reduce restenosis after interventions in coronary or femoropopliteal arteries. The investigators confirmed and published periprocedural cilostazol administration reduced incidences of in-stent restenosis (ISR) or target vessel revascularization (TVR) after CAS, retrospectively.
CAS-CARE study is Multicenter Prospective Ranodomized Controlled Study. Patients, scheduled for CAS within 30 days, 50% or more symptomatic carotid stenosis or 80% or more asymptomatic carotid stenosis, will enroll and randomize by cilostazol/non-cilostazol group. 900 patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after CAS, evaluated by carotid ultrasound and angiography. And, evaluate cardiovascular events, including stroke, myocardial infarction, and hemorrhagic events in periprocedural period and followed period. In this study, ISR is diagnosed by ultrasound and DSA/CTA. Equivalence of CTA to ultrasound will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol group | Experimental | Drug: Cilostazol or Non-CilostazolContinuous administration of cilostazol (unrestricted use of other antiplatelet agents and concomitant drugs) |
| Non-Cilostazol group | Active comparator | Drug: Cilostazol or Non-CilostazolAntiplatelet agent other than cilostazol (unrestricted use of concomitant drugs) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 50% or more symptomatic carotid artery stenosis or 80% or more asymptomatic carotid artery stenosis
- scheduled for carotid artery stenting within 30 days
- 45 or more years-old and less than 80 years old
- antiplatelet agents can be administratered orally
- follow-up is anticipated possible for 2 years after CAS
Key exclusion criteria (7 listed)
- received endovascular interevention
- scheduled for bilateral carotid intervention
- aortitis or cvasculitis
- congessive heart failure
- ischemic stroke within 48 hours
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 |
|---|---|---|
| Cilostazol or Non-CilostazolAlso: Cilostazol (Pretal) group, Non-Cilostazol (Pretal) groupCilostazol group administrate 100-200mg/day per oral, unrestricted use of other antiplatelet agents and concomitant drugs. | Drug | Cilostazol group, Non-Cilostazol group |
Primary outcome
Presence or absence of in-stent restenosis within 2 years after CAS and time to occurrence
Time frame: 2 years
Difinition of endpoint is 50% or more in-stent restenosis detected by carotid ultrasound or angiopraphy. In cases restenosis does not occur, the final observation point will be used as the final evaluation point.
7 secondary outcomes
Cardiovascular event, death, hemorrhagic event, in-stent restenosis, new out-stent stenosis, or retreatment of stented artery within 2 yrs
Time frame: 2 years
In-stent restenosis, new out-stent stenosis, or retreatment within 2 years
Time frame: 2 years
hemorrhagic event within 2 years
Time frame: 2 years
stroke within 2 years
Time frame: 2 years
In-stent restenosis, new out-stent stenosis, or retreatment of stented artery, cardiovascular event, or death from any cause within 30 days
Time frame: 30 days
Severe in-stent restenosis within 2 yrs
Time frame: 2 yeras
Change from baseline in max-IMT in both common carotid arteries
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Derived from this study: PubMed 39585936Yamagami H, Ozaki T, Ogasawara K, Nagata I, Matsumaru Y, Yoshimura S, Sasaki M, Nagatsuka K, Minematsu K, Nagai Y, Sakai C, Matsumoto Y, Ezura M, Ishihara H, Sakai N; CAS-CARE Investigators. Randomized Controlled Trial of Cilostazol Addition for In-Stent Restenosis After Carotid Artery Stenting. Stroke. 2024 Dec;55(12):2776-2785. doi: 10.1161/STROKEAHA.124.047210. Epub 2024 Nov 25.
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.
Nobuyuki Sakai, MD, DMSc principal investigator
Kobe City Medical Center General Hospital
Hiroshi Yamagami, MD, PhD principal investigator
Kobe City Medical Center General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cilostazol or Non-Cilostazol in people with In-stent Restenosis After Carotid Artery Stenting, run by Kobe City General Hospital at 1 site in Japan.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 16 Oct 2019. 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 Japan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of in-stent restenosis within 2 years after CAS and time to occurrence (time frame: 2 years). 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 NCT01261234, 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 16 Oct 2019.