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

October 4, 2005
June 9, 2011
December 2003
December 2008   (final data collection date for primary outcome measure)
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.
Occurrence of cerebral stroke (cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage)
Complete list of historical versions of study NCT00234065 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
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Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
Post-marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cerebral Infarction
  • Drug: Cilostazol
    oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years
  • Drug: Aspirin
    oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years
  • Experimental: 1
    cilostazol
    Intervention: Drug: Cilostazol
  • Active Comparator: 2
    Aspirin
    Intervention: Drug: Aspirin
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. Epub 2010 Sep 15. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2800
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00234065
C02100-002, JapicCTI-050034, UMIN-CTR-C000000129
Yes
Katsuhisa Saito, OPCJ
Otsuka Pharmaceutical Co., Ltd.
Not Provided
Study Director: Masahiko Abe Division of New Product Evaluation and Development
Otsuka Pharmaceutical Co., Ltd.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP