Carotid Artery Stenting With Cilostazol Addition for Restenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

707 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent

NCT00589927

Coronary Artery Disease

COMPLETED PHASE4

A Blinded Study Conducted at Multiple Centers Evaluating Various Doses of an Investigational Agent (BO-653) Against Placebo, for Safety and Effectiveness in Preventing Post-Angioplasty Blood Vessel Re-Closure (Restenosis) in Stented Vessels.

NCT00055510

Graft Occlusion, Vascular Coronary Restenosis Atherosclerosis

COMPLETED PHASE2/PHASE3

Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes

NCT02850081

Carotid Artery Stenosis Strokes

COMPLETED PHASE3

Effects of Short-term Intensive Statin Therapy on Lipid Levels

NCT07344610

Ischemic Stroke

RECRUITING

Statin and Dual Antiplatelet Therapy to Prevent Early Neurological Deterioration in Branch Atheromatous Disease

NCT04824911

Acute Stroke Dual Antiplatelet Therapy Statin

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

In-stent Restenosis After Carotid Artery Stenting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cilostazol group

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

Group Type EXPERIMENTAL

Cilostazol or Non-Cilostazol

Intervention Type DRUG

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

Non-Cilostazol group

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

Group Type ACTIVE_COMPARATOR

Cilostazol or Non-Cilostazol

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cilostazol or Non-Cilostazol

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cilostazol (Pretal) group Non-Cilostazol (Pretal) group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No