CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,578 enrolled
Drug / intervention
Pravastatindrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Ischemic stroke (non-cardiogenic) occurring 1 month to 3 years prior to enrollment
  • ✓Hyperlipidemia with total cholesterol 180-240 mg/dL
  • ✓No statin therapy in the 30 days prior to screening
  • ✓Able to attend outpatient clinic visits
Key exclusion· 8
  • ✕Ischemic stroke of determined etiology other than atherosclerotic disease per TOAST classification
  • ✕Ischemic heart disease requiring statin therapy
  • ✕Hemorrhagic disorders
  • ✕Platelet count ≤100,000/μL within 3 months before study start

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

Search/NCT00221104
NCT00221104Phase 3Completed
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Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan·interventional·Posted Sep 22, 2005·Updated Jan 25, 2018

In Brief

A Phase 3 clinical trial evaluating Pravastatin for Ischemic Stroke. Completed, enrolled 1,578 participants across 1 site.

Detailed Summary

Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Stroke
CountriesJapan
CollaboratorsMinistry of Health, Labour and Welfare, Japan, Hiroshima University

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartMar 1, 2004
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 20.8 years ago

Interventions

Pravastatindrug