CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 457 enrolled
Drug / intervention
clopidogrel +1 moredrug
Likely dose
Cilostazol 100 mg orally twice daily or Clopidogrel 75 mg orally once dailyAI-extracted
Key inclusion· 3
  • Cerebral infarction or TIA with acute ischemic brain lesion on MRI within 2 weeks of onset
  • Age over 35 years
  • Significant focal stenosis in M1 segment of middle cerebral artery (MCA) or basilar artery (BA) with acute ischemic lesions in the territory of the stenosed artery
Key exclusion· 12
  • Contraindications to antiplatelet therapy
  • Cardiac embolic sources including prosthetic valve, atrial fibrillation/flutter, cardiac thrombus, cardiomyopathy, or recent myocardial infarction (within 4 weeks)
  • More than 50% stenosis in the parent artery of symptomatic stenosis
  • Bleeding diathesis

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

Search/NCT00130039
NCT00130039Phase 4Completed

Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel

Asan Medical Center·interventional·Posted Aug 15, 2005·Updated Jan 12, 2010

In Brief

A Phase 4 clinical trial evaluating clopidogrel and Cilostazol for Cerebral Infarction and Atherosclerosis. Completed, enrolled 457 participants across 19 sites in 4 countries.

Detailed Summary

This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of Middle cerebral artery (MCA) or basilar artery). They will be randomly assigned into cilostazol group or clopidogrel group. Every patients will take 100mg of aspirin a day additionally. The primary outcome variable of this study is Progression rate of symptomatic intracranial stenosis on magnetic resonance angiogram (MRA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong, Philippines, South Korea, Thailand

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2005
Enrollment StartAug 1, 2005
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.9 years ago

Interventions

clopidogreldrug

Clopidogrel 75mg once a day plus placebo of cilostazol twice a day

Cilostazoldrug

Cilostazol 100mg twice a day plus placebo of clopidogrel once a day