Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II — TOSS-2  

Atherosclerosis Clinical Trial

Official title: Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel

Status Completed

Clinical Trial Summary

This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of Middle cerebral artery (MCA) or basilar artery).

They will be randomly assigned into cilostazol group or clopidogrel group. Every patients will take 100mg of aspirin a day additionally.

The primary outcome variable of this study is Progression rate of symptomatic intracranial stenosis on magnetic resonance angiogram (MRA).

Clinical Trial Description

[Goal] To Reveal the Effect and Safety of Cilostazol Compared with Clopidogrel on the Prevention of the Progression of Symptomatic Intracranial Arterial Stenosis.

[Trial Design] Double-Blind, Active-Controlled, Randomized, Multicenter Trial

[Participants] Acute ischemic stroke patients with symptomatic intracranial arterial stenosis

[Methods]

• Double-Blind, Active-Controlled, Randomized, Multicenter Trial

• Investigational product (Double Dummy Method):

Cilostazol 200mg (100mg twice per day) versus clopidogrel 75mg

• Concomitant medication: Aspirin 100 (75-150) mg per day

• Medication Duration: 7 months

[Outcome Variables]

Primary Outcome Variable:

• Progression rate of symptomatic intracranial arterial stenosis

Secondary outcome variables:

• The occurrence of new MRI (magnetic resonance image) lesion on follow-up MRI

• Stroke events

• Overall cardiovascular events: stroke, acute coronary syndrome, vascular death

• Ipsilateral ischemic stroke rate

• Fatal or major bleeding complications ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Cerebral Infarction
• Infarction

• NCT number: NCT00130039
• Study type: Interventional
• Source: Asan Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: August 2005
• Completion date: January 2009