Carotid Artery Stenting With Cilostazol Addition for Restenosis (CAS-CARE)
This study is enrolling participants by invitation only.
Sponsor:
Kobe City General Hospital
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
Information provided by (Responsible Party):
Nobuyuki Sakai, Kobe City General Hospital
ClinicalTrials.gov Identifier:
NCT01261234
First received: December 11, 2010
Last updated: October 14, 2012
Last verified: October 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 11, 2010 | ||||||||
| Last Updated Date | October 14, 2012 | ||||||||
| Start Date ICMJE | December 2010 | ||||||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Presence or absence of in-stent restenosis within 2 years after CAS and time to occurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01261234 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Carotid Artery Stenting With Cilostazol Addition for Restenosis | ||||||||
| Official Title ICMJE | Effect of Cilostazol on In-stent Restenosis After Carotid Artery Stenting; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial | ||||||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | In-stent Restenosis After Carotid Artery Stenting | ||||||||
| Intervention ICMJE | Drug: Cilostazol or Non-Cilostazol
Cilostazol group administrate 100-200mg/day per oral, unrestricted use of other antiplatelet agents and concomitant drugs.
Other Names:
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||
| Estimated Enrollment ICMJE | 900 | ||||||||
| Estimated Completion Date | March 2016 | ||||||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 45 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Japan | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01261234 | ||||||||
| Other Study ID Numbers ICMJE | TRIBRAIN1010, UMIN000004705 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Nobuyuki Sakai, Kobe City General Hospital | ||||||||
| Study Sponsor ICMJE | Kobe City General Hospital | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Kobe City General Hospital | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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