Phase 4
N=2,716
Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
Cerebral Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00234065 ↗Enrolled (actual)
2,716
Serious AEs
30.1%
Results posted
May 2011
Primary outcome: Primary: Numbers of Patients With First Occurence of Stroke — 82; 119 participants — p=0.0357
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cilostazol (Drug); Aspirin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numbers of Patients With First Occurence of Stroke |
82; 119 | 0.0357 sig |
| SECONDARY Number of Patients With First Recurrence of Cerebral Infarction |
72; 88 | 0.4189 |
| SECONDARY Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease |
86; 103 | 0.4582 |
| SECONDARY Number of Deaths From Any Cause |
13; 13 | 0.8600 |
| SECONDARY Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events |
138; 186 | 0.0437 sig |
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).
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
Data sourced from ClinicalTrials.gov (NCT00234065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.