CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,800 enrolled
Drug / intervention
Cilostazol +1 moredrug
Likely dose
Cilostazol 100 mg twice daily or Aspirin 81 mg once dailyAI-extracted
Key inclusion· 5
  • Stable medical condition for at least 26 weeks after cerebral infarction
  • Age 20-80 years at time of consent
  • Infarct-related foci confirmed on imaging (CT or MRI)
  • No cardiogenic embolic sources (mitral stenosis, prosthetic valve, endocarditis, recent MI, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse in <45 years without other cause, atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, patent foramen ovale)
Key exclusion· 10
  • Hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, GI/urinary/other hemorrhage, hemoptysis, vitreous hemorrhage)
  • Pregnancy or nursing
  • Ischemic heart failure
  • Peptic ulcer disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00234065
NCT00234065Phase 4Completed

Post-marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Oct 6, 2005·Updated Jun 10, 2011

In Brief

A Phase 4 clinical trial evaluating Cilostazol and Aspirin for Cerebral Infarction. Completed, enrolled 2,800 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 6, 2005
Enrollment StartDec 1, 2003
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.7 years ago

Interventions

Cilostazoldrug

oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years

Aspirindrug

oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years