Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333164
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2006-06-01
Brief Title:
Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis
Sponsor:
Translational Research Center for Medical Innovation Kobe Hyogo Japan
Organization:
Translational Research Center for Medical Innovation Kobe Hyogo Japan
Study Overview
Official Title:
Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis CATHARSIS
Status:
COMPLETED
Status Verified Date:
2012-08
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:
None
Brief Summary:
Multi-center open-labelled randomized controlled trial to study the effect of aspirin plus cilostazol and aspirin alone on the progression of intracranial arterial stenosis in 200 chronic stroke patients with 50-99 stenosis to be followed up for 2 years
Detailed Description:
Intracraial arterial stenosis IAS is more common in Asia including Japanese than in Cocasian Also stroke recurrence rate is high in patients with such lesions despite medical treatment Accoding to the result of WASID N Engl J Med 20053521305-16 warfarin is not recommended because of the concern of safety higher risk of intracranial hemorrhage and death when compared with aspirin wheras the efficacy of aspirin is not enough in symptomatic IAS patients Under these conditions we planned to conduct a nationwide multi-center open labelled randomized controlled trial to compare the effect of aspirin plus cilostazol phosphodiestrase type 3 inhibitor and aspirin alone on the progression of IAS in 200 IAS patients with ischemic stroke after 2 weeks to 6 months of onset Patients are randomly allocated to either of two groups Aspirin 100mgday plus cilostazol 200 mgday is given to the 100 patients in one group and aspirin 100 mgday alone is given to 100 patients in another group
Follow-up period is at least two years The primary endpoint is progression of IAS on MRA at two years after randomization The secondary endpoints are cardiovascular events ischemic stroke myocardial infarct and other vascular events death serious adverse events new silent brain infarcts and activity of daily life The purpose of this study is to establish the best medical treatment in symptomatic IAS patients This study will also provide important information for the future randomized controlled study to compare medical treatment alone and intravascular intervetnion PTA andor stenting in these patients
Follow-up period is at least two years The primary endpoint is progression of IAS on MRA at two years after randomization The secondary endpoints are cardiovascular events ischemic stroke myocardial infarct and other vascular events death serious adverse events new silent brain infarcts and activity of daily life The purpose of this study is to establish the best medical treatment in symptomatic IAS patients This study will also provide important information for the future randomized controlled study to compare medical treatment alone and intravascular intervetnion PTA andor stenting in these patients
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