Cilostazol Stroke Prevention Study for Antiplatelet Combination
NCT01995370 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1884
Last updated 2019-03-28
Summary
To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for secondary prevention of ischemic stroke in high-risk patients for stroke
Conditions
- Noncardioembolic Cerebral Infarction
Interventions
- DRUG
-
Aspirin (81mg or 100mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
- DRUG
-
clopidogrel
Clopidogrel (50mg or 75mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
- DRUG
-
cilostazol
Cilostazol (100mg twice daily) will be orally administered. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
Sponsors & Collaborators
-
Otsuka Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Japan Cardiovascular Research Foundation
lead OTHER
Principal Investigators
-
Takenori Yamaguchi, President emeritus · National Cerebral and Cardiovascular Center, Japan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-13
- Primary Completion
- 2018-12-07
- Completion
- 2018-12-07
Countries
- Japan
Study Locations
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