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Post-Marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
This study is ongoing, but not recruiting participants.
Study NCT00234065   Information provided by Otsuka Pharmaceutical Co., Ltd.
First Received: October 4, 2005   Last Updated: April 23, 2008   History of Changes

October 4, 2005
April 23, 2008
December 2003
December 2008   (final data collection date for primary outcome measure)
Occurrence of cerebral stroke (cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage) [ Time Frame: every time ] [ Designated as safety issue: Yes ]
Occurrence of cerebral stroke (cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage)
Complete list of historical versions of study NCT00234065 on ClinicalTrials.gov Archive Site
 
 
 
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).

 
Phase IV
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Cerebral Infarction
  • Drug: Cilostazol
  • Drug: Aspirin
  • Experimental: cilostazol
  • Active Comparator: Aspirin
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
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
Katsuhisa Saito, OPCJ
C02100-002, JapicCTI-050034, UMIN-CTR-C000000129
Otsuka Pharmaceutical Co., Ltd.
 
Study Director: Katsuhisa Saito Division of New Product Evaluation and Development
Otsuka Pharmaceutical Co., Ltd.
April 2008

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