Back to resultsPost-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
Primary Purpose
Cerebral Infarction
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Cilostazol
Aspirin
Sponsored by
About this trial
This is an interventional prevention trial for Cerebral Infarction
Eligibility Criteria
Inclusion Criteria: Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI Patients aged 20 to 80 years (inclusive) at time of consent Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale Patients without asymptomatic cerebral infarction Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction Patients without severe disturbances/impairments following occurrence of cerebral Exclusion Criteria: Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body) Pregnant, possibly pregnant, or nursing women Patients with ischemic heart failure Patients with peptic ulcer Patients with severer blood disorders Patients with severe hepatic or renal Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma Patients who are being treated with ticlopidine hydrochloride Patients who are participating in another study for an investigational drug Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
Sites / Locations
- Otsuka Pharmaceutical Co., Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
cilostazol
Aspirin
Outcomes
Primary Outcome Measures
Numbers of Patients With First Occurence of Stroke
The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Secondary Outcome Measures
Number of Patients With First Recurrence of Cerebral Infarction
Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease
The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction or the first occurrence of transient ischaemic attack. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Number of Deaths From Any Cause
Number of deaths from any cause. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events
The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage, subarachnoid haemorrhage, transient ischaemic attack, angina pectris, myocardial infarction, heart failure, or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Full Information
NCT ID
NCT00234065
First Posted
October 4, 2005
Last Updated
June 9, 2011
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00234065
Brief Title
Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
Official Title
Post-marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
cilostazol
Arm Title
2
Arm Type
Active Comparator
Arm Description
Aspirin
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Intervention Description
oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years
Primary Outcome Measure Information:
Title
Numbers of Patients With First Occurence of Stroke
Description
The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Time Frame
From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])
Secondary Outcome Measure Information:
Title
Number of Patients With First Recurrence of Cerebral Infarction
Time Frame
From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
Title
Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease
Description
The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction or the first occurrence of transient ischaemic attack. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Time Frame
From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
Title
Number of Deaths From Any Cause
Description
Number of deaths from any cause. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Time Frame
From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
Title
Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events
Description
The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage, subarachnoid haemorrhage, transient ischaemic attack, angina pectris, myocardial infarction, heart failure, or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Time Frame
From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
Other Pre-specified Outcome Measures:
Title
Number of Patients With First Occurrence of Haemorrhagic Event
Description
The endpoint in this measure is a composite endpoint of the first occurrence of cerebral haemorrhage, subarachnoid haemorrhage or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Time Frame
From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI
Patients aged 20 to 80 years (inclusive) at time of consent
Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale
Patients without asymptomatic cerebral infarction
Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
Patients without severe disturbances/impairments following occurrence of cerebral
Exclusion Criteria:
Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
Pregnant, possibly pregnant, or nursing women
Patients with ischemic heart failure
Patients with peptic ulcer
Patients with severer blood disorders
Patients with severe hepatic or renal
Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
Patients who are being treated with ticlopidine hydrochloride
Patients who are participating in another study for an investigational drug
Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masahiko Abe
Organizational Affiliation
Division of New Product Evaluation and Development
Official's Role
Study Director
Facility Information:
Facility Name
Otsuka Pharmaceutical Co., Ltd.
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
20833591
Citation
Shinohara Y, Katayama Y, Uchiyama S, Yamaguchi T, Handa S, Matsuoka K, Ohashi Y, Tanahashi N, Yamamoto H, Genka C, Kitagawa Y, Kusuoka H, Nishimaru K, Tsushima M, Koretsune Y, Sawada T, Hamada C; CSPS 2 group. Cilostazol for prevention of secondary stroke (CSPS 2): an aspirin-controlled, double-blind, randomised non-inferiority trial. Lancet Neurol. 2010 Oct;9(10):959-68. doi: 10.1016/S1474-4422(10)70198-8. Epub 2010 Sep 15.
Results Reference
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Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
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