Carotid Artery Stenting With Cilostazol Addition for Restenosis (CAS-CARE)

This study is enrolling participants by invitation only.
Sponsor:
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
  Purpose

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.


Condition Intervention Phase
In-stent Restenosis After Carotid Artery Stenting
Drug: Cilostazol or Non-Cilostazol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Cilostazol on In-stent Restenosis After Carotid Artery Stenting; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial

Resource links provided by NLM:


Further study details as provided by Kobe City General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Cardiovascular event, death, hemorrhagic event, in-stent restenosis, new out-stent stenosis, or retreatment of stented artery within 2 yrs [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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

  • In-stent restenosis, new out-stent stenosis, or retreatment within 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    In-stent restenosis, new out-stent stenosis detected by ultrasound or CTA/DSA, or retreatment of stented artery within 2 years

  • hemorrhagic event within 2 years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    hemorrhagic stroke, major hemorrhage required 2 unit or more transfusion

  • stroke within 2 years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    any ischemic or hemorrhagic stroke

  • 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 ] [ Designated as safety issue: Yes ]
    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

  • Severe in-stent restenosis within 2 yrs [ Time Frame: 2 yeras ] [ Designated as safety issue: No ]
    70% or more in-stent restenosis, diagnosed by ultrasound or DSA/CTA,

  • Change from baseline in max-IMT in both common carotid arteries [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Intima-Media thickness of common carotid artery measured by ultrasound


Estimated Enrollment: 900
Study Start Date: December 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cilostazol group
Continuous administration of cilostazol (unrestricted use of other antiplatelet agents and concomitant drugs)
Drug: Cilostazol or Non-Cilostazol
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
Active Comparator: Non-Cilostazol group
Antiplatelet agent other than cilostazol (unrestricted use of concomitant drugs)
Drug: Cilostazol or Non-Cilostazol
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

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

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261234

Locations
Japan
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan, 650-0046
Sponsors and Collaborators
Kobe City General Hospital
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
Investigators
Principal Investigator: Nobuyuki Sakai, MD, DMSc Kobe City Medical Center General Hospital
Principal Investigator: Hiroshi Yamagami, MD, PhD Kobe City Medical Center General Hospital
  More Information

No publications provided

Responsible Party: Nobuyuki Sakai, Director, Neurosurgery, Kobe City General Hospital
ClinicalTrials.gov Identifier: NCT01261234     History of Changes
Other Study ID Numbers: TRIBRAIN1010, UMIN000004705
Study First Received: December 11, 2010
Last Updated: October 14, 2012
Health Authority: Japan: Foundation for Biomedical Research and Innovation

Keywords provided by Kobe City General Hospital:
Carotid Artery Disease
Carotid Artery Stenting
In stent restenosis
Cardiovascular event
Intima Media Thickness

Additional relevant MeSH terms:
Cilostazol
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 24, 2014