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Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00234065
First received: October 4, 2005
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Cerebral Infarction
 Drug: Cilostazol
Drug: Aspirin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Post-marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Numbers of Patients With First Occurence of Stroke [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months]) ] [ Designated as safety issue: No ]
    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 [ 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]) ] [ Designated as safety issue: No ]
  • Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) ] [ Designated as safety issue: No ]
    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.


Enrollment: 2800
Study Start Date: December 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
cilostazol
 Drug: Cilostazol
oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years
Active Comparator: 2
Aspirin
 Drug: Aspirin
oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
  2. Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI
  3. Patients aged 20 to 80 years (inclusive) at time of consent
  4. 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
  5. Patients without asymptomatic cerebral infarction
  6. Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
  7. Patients without severe disturbances/impairments following occurrence of cerebral

Exclusion Criteria:

  1. 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)
  2. Pregnant, possibly pregnant, or nursing women
  3. Patients with ischemic heart failure
  4. Patients with peptic ulcer
  5. Patients with severer blood disorders
  6. Patients with severe hepatic or renal
  7. Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
  8. Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
  9. Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
  10. Patients who are being treated with ticlopidine hydrochloride
  11. Patients who are participating in another study for an investigational drug
  12. Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234065

Locations
Japan
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Masahiko Abe Division of New Product Evaluation and Development
  More Information

Publications:

Responsible Party: Katsuhisa Saito, OPCJ
ClinicalTrials.gov Identifier: NCT00234065     History of Changes
Other Study ID Numbers: C02100-002, JapicCTI-050034, UMIN-CTR-C000000129
Study First Received: October 4, 2005
Results First Received: April 19, 2011
Last Updated: June 9, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Aspirin
 Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013