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The Effects of Very Early Use of Rosuvastatin in Preventing Recurrence of Ischemic Stroke

NCT01364220 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2014-11-20

No results posted yet for this study

Summary

It is anticipated that 548 subjects will be recruited from approximately 27 centres in South Korea.

This is an investigator-sponsored, double-blind, placebo-controlled, randomized, multi-centre study to assess the effects of rosuvastatin 20 mg compared to placebo in acute ischemic stroke patients, with the first dose within 18 hours after baseline MRI and continued treatment for 14 days.

Subjects will be male or female, over 20 years, with diagnosis of acute ischemic stroke with baseline MRI, and who are either statin-naïve or untreated with statin for the previous 3 months.

The objective would be to compare the recurrence rate of ischemic stroke by comparing the imaging parameters during 14 days of treatment and clinical improvement as defined by percent improvement based on NIHSS scores measurements at baseline, 5 days and 14 days of treatment.

Conditions

Interventions

DRUG

Rosuvastatin

Rosuvastatin 20mg tablet, once daily, for 14 days

OTHER

Placebo tablet

Placebo tablet, once daily, for 14 days

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Severance Hospital

    lead OTHER

Principal Investigators

  • Ji Hoe Heo, MD., Ph. D · Department of Neurology, Severance Hospital, 250 Seongsan-no,Seodaemun-gu,Seoul,120-752, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01364220 on ClinicalTrials.gov