Clinical trial NCT01261234: Carotid Artery Stenting With Cilostazol Addition for Restenosis
Official title: Effect of Cilostazol on In-stent Restenosis After Carotid Artery Stenting; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: In-stent Restenosis After Carotid Artery Stenting
Keywords: Carotid Artery Disease
Carotid Artery Stenting
In stent restenosis
Cardiovascular event
Intima Media Thickness
Lead sponsor: Kobe City General Hospital
Sponsor class: OTHER
Collaborators: name: Chiba University
name: Nagoya University
name: Mie University
name: Wakayama Medical University
name: Kyoto University
name: Osaka University
name: Kobe University
name: Foundation for Biomedical Research and Innovation
name: Okayama University
name: Yamaguchi University Hospital
name: Fukuoka University
name: Nagasaki University
First posted: 2010-12-16
Enrollment: 707
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Presence or absence of in-stent restenosis within 2 years after CAS and time to occurrence
timeFrame: 2 years
Secondary outcomes:
measure: Cardiovascular event, death, hemorrhagic event, in-stent restenosis, new out-stent stenosis, or retreatment of stented artery within 2 yrs
timeFrame: 2 years
measure: In-stent restenosis, new out-stent stenosis, or retreatment within 2 years
timeFrame: 2 years
measure: hemorrhagic event within 2 years
timeFrame: 2 years
measure: stroke within 2 years
timeFrame: 2 years
measure: In-stent restenosis, new out-stent stenosis, or retreatment of stented artery, cardiovascular event, or death from any cause within 30 days
timeFrame: 30 days
measure: Severe in-stent restenosis within 2 yrs
timeFrame: 2 yeras
measure: Change from baseline in max-IMT in both common carotid arteries
timeFrame: 2 years
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
Study officials:
affiliation: Kobe City Medical Center General Hospital
name: Nobuyuki Sakai, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Kobe City Medical Center General Hospital
name: Hiroshi Yamagami, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: