Post-marketing Study of Cilostazol (Cilostazol Stroke Pre... | NCT00234065

NCT00234065

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
1	Experimental	cilostazol	Drug: Cilostazol
2	Active Comparator	Aspirin	Drug: Aspirin

Name	Type	Description	Arm Group Labels	Other Names
Cilostazol	Drug	oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])

Secondary Outcomes

Measure	Description	Time Frame
Number of Patients With First Recurrence of Cerebral Infarction		From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease

Other Outcomes

Measure	Description	Time Frame
Number of Patients With First Occurrence of Haemorrhagic Event	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.	From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])

Eligibility Module

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

Name	Affiliation	Role
Masahiko Abe	Division of New Product Evaluation and Development	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20833591	Result	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.

ID	Title	Description
FG000	Cilostazol	cilostazol, oral tablet, 100 mg cilostazol
FG001	Aspirin	Aspirin, oral tablet, 81 mg aspirin

Baseline Characteristics Module

ID	Title	Description
BG000	Cilostazol	cilostazol, oral tablet, 100 mg cilostazol
BG001	Aspirin	Aspirin, oral tablet, 81 mg aspirin

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.

Posted

Number

participants

From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])

ID	Title	Description
OG000	Cilostazol	cilostazol, oral tablet, 100 mg cilostazol

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cilostazol	cilostazol, oral tablet, 100 mg cilostazol

ID	Term
D020520	Brain Infarction
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Type	Description	Link
JapicCTI-050034
UMIN-CTR-C000000129