Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130039
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2005-08-11
Brief Title:
Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOSS-2
Brief 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
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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None