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Completed

NCT Number: NCT01261234

Carotid Artery Stenting With Cilostazol Addition for Restenosis

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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Key information

Conditions

In-stent Restenosis After Carotid Artery Stenting Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0046, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cilostazol or Non-Cilostazol

Drug

Cilostazol group administrate 100-200mg/day per oral, unrestricted use of other antiplatelet agents and concomitant drugs.

Other names: Cilostazol (Pretal) group, Non-Cilostazol (Pretal) group

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cardiovascular event, death, hemorrhagic event, in-stent restenosis, new out-stent stenosis, or retreatment of stented artery within 2 yrs

    Time frame: 2 years

    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

  2. In-stent restenosis, new out-stent stenosis, or retreatment within 2 years

    Time frame: 2 years

    In-stent restenosis, new out-stent stenosis detected by ultrasound or CTA/DSA, or retreatment of stented artery within 2 years

  3. hemorrhagic event within 2 years

    Time frame: 2 years

    hemorrhagic stroke, major hemorrhage required 2 unit or more transfusion

  4. stroke within 2 years

    Time frame: 2 years

    any ischemic or hemorrhagic stroke

  5. 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

    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

  6. Severe in-stent restenosis within 2 yrs

    Time frame: 2 yeras

    70% or more in-stent restenosis, diagnosed by ultrasound or DSA/CTA,

  7. Change from baseline in max-IMT in both common carotid arteries

    Time frame: 2 years

    Intima-Media thickness of common carotid artery measured by ultrasound

Sponsors and collaborators

Lead sponsor

Kobe City General Hospital

Other

Collaborators

  • Chiba University
  • Foundation for Biomedical Research and Innovation
  • Fukuoka University
  • Kobe University
  • Kyoto University
  • Mie University
  • Nagasaki University
  • Nagoya University
  • Okayama University
  • Osaka University
  • Wakayama Medical University
  • Yamaguchi University Hospital

Registry information

Official study title

Effect of Cilostazol on In-stent Restenosis After Carotid Artery Stenting; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial

Acronym: CAS-CARE

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Dec 16, 2010
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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