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

Kobe City General Hospital

Status: Completed

Conditions: In-stent Restenosis After Carotid Artery Stenting

Treatments: Drug: Cilostazol or Non-Cilostazol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01261234

UMIN000004705 (Other Identifier)

TRIBRAIN1010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 707 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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707 participants in 2 patient groups

Cilostazol group

Experimental group

Description:

Continuous administration of cilostazol (unrestricted use of other antiplatelet agents and concomitant drugs)

Treatment:

Drug: Cilostazol or Non-Cilostazol

Non-Cilostazol group

Active Comparator group

Description:

Antiplatelet agent other than cilostazol (unrestricted use of concomitant drugs)

Treatment:

Drug: Cilostazol or Non-Cilostazol