Carotid Artery Stenting With Cilostazol Addition for Restenosis
CAS-CARE
Effect of Cilostazol on In-stent Restenosis After Carotid Artery Stenting; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial
2 other identifiers
interventional
707
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 11, 2010
CompletedFirst Posted
Study publicly available on registry
December 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedOctober 16, 2019
October 1, 2019
8.3 years
December 11, 2010
October 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
2 years
In-stent restenosis, new out-stent stenosis, or retreatment within 2 years
2 years
hemorrhagic event within 2 years
2 years
stroke within 2 years
2 years
In-stent restenosis, new out-stent stenosis, or retreatment of stented artery, cardiovascular event, or death from any cause within 30 days
30 days
- +2 more secondary outcomes
Study Arms (2)
Cilostazol group
EXPERIMENTALContinuous administration of cilostazol (unrestricted use of other antiplatelet agents and concomitant drugs)
Non-Cilostazol group
ACTIVE COMPARATORAntiplatelet agent other than cilostazol (unrestricted use of concomitant drugs)
Interventions
Cilostazol group administrate 100-200mg/day per oral, unrestricted use of other antiplatelet agents and concomitant drugs.
Eligibility Criteria
You may qualify if:
- % or more symptomatic carotid artery stenosis or 80% or more asymptomatic carotid artery stenosis
- scheduled for carotid artery stenting within 30 days
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kobe City General Hospitallead
- Chiba Universitycollaborator
- Nagoya Universitycollaborator
- Mie Universitycollaborator
- Wakayama Medical Universitycollaborator
- Kyoto Universitycollaborator
- Osaka Universitycollaborator
- Kobe Universitycollaborator
- Foundation for Biomedical Research and Innovationcollaborator
- Okayama Universitycollaborator
- Yamaguchi University Hospitalcollaborator
- Fukuoka Universitycollaborator
- Nagasaki Universitycollaborator
Study Sites (1)
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0046, Japan
Related Publications (1)
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.
PMID: 39585936DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nobuyuki Sakai, MD, DMSc
Kobe City Medical Center General Hospital
- PRINCIPAL INVESTIGATOR
Hiroshi Yamagami, MD, PhD
Kobe City Medical Center General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Neurosurgery
Study Record Dates
First Submitted
December 11, 2010
First Posted
December 16, 2010
Study Start
December 1, 2010
Primary Completion
March 1, 2019
Study Completion
September 1, 2019
Last Updated
October 16, 2019
Record last verified: 2019-10