Status:
COMPLETED
Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
Foundation for Biomedical Research and Innovation
Neurology, Tokyo Women's Medical University, School of Medicine
Conditions:
Cerebrovascular Disease
Eligibility:
All Genders
45-85 years
Phase:
PHASE3
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 pa...
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. Accodin...
Eligibility Criteria
Inclusion
- (1) Ischemic stroke after two weeks to six months from onset,
- (2) Responsible lesion identified on MRI,
- ( 3) Intracranial arterial stenosis \>50% on MRA in the territory of responsible lesion,
- (4) Intracranial arterial stenosis in suproclinoid internal carotid arterry, M1 portion of midlle cerebral artery, or basilar artery,
- (5) Age of 45 to 85 years,
- (6) Able to visit out-patient clinic, and
- (7) Written informed consent obtained from patient or family.
Exclusion
- (1) Patients with potential cardiac embolic sources,
- (2) Patients receiving cilostazol,
- (3) Patients on warfarin treatment,
- (4) Patients in whom MRI cannot be perfomed,
- (5) Patients in whom PTA or bypass surgery is planned,
- (6) Patients with history of symptomatic intracranial hemorrhage, other hemorrhagic diseases (active peptic ulcer etc.), hemophilia or coagulation abnormalities,
- (7) Patients with hypersensitivity to cilostazol or aspirin,
- (8) Patients with congestive heart failure or uncontrollable angina pectoris,
- (9) Patients with thrombocytopenia (\<100,000/mm3),
- (10) Patients with liver dysfunction (AST or ALT \>100 IU/L),
- (11) Patients with renal dysfunction (Creatinin \>2.0 mg/dl),
- (12) Patients who cannot to be followed up during the study period,
- (13) Patients who are enrolled in other clinical trials, and
- (14) Patients inadequate for this study by other reasons.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00333164
Start Date
May 1 2006
End Date
March 1 2012
Last Update
December 19 2017
Active Locations (1)
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1
Tokyo Women's Medical University School of Medicine
Shinjuku-ku, Tokyo, Japan, 162-8666