DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Carotid Artery Stenting With Cilostazol Addition for Restenosis

Information source: Kobe City General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: In-stent Restenosis After Carotid Artery Stenting

Intervention: Cilostazol or Non-Cilostazol (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Kobe City General Hospital

Official(s) and/or principal investigator(s):
Nobuyuki Sakai, MD, DMSc, Principal Investigator, Affiliation: Kobe City Medical Center General Hospital
Hiroshi Yamagami, MD, PhD, Principal Investigator, Affiliation: Kobe City Medical Center General Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Presence or absence of in-stent restenosis within 2 years after CAS and time to occurrence

Secondary outcome:

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

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

hemorrhagic event within 2 years

stroke within 2 years

In-stent restenosis, new out-stent stenosis, or retreatment of stented artery, cardiovascular event, or death from any cause within 30 days

Severe in-stent restenosis within 2 yrs

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

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

Minimum age: 45 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Kobe City Medical Center General Hospital, Kobe, Hyogo 650-0046, Japan
Additional Information

Starting date: December 2010
Last updated: October 14, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017