Neuroprotection with Statin Therapy for Acute Recovery Trial (Neu START):A Phase 2 safety and pilot efficacy study of lovastatin for the treatment of acute ischemic stroke [SPOTRIAS] "NeuSTART II"
Recruiting
Phase N/A Results N/ASummary of Purpose
To determine whether lovastatin 640 mg daily for 3 days beginning within 24 hours after acute stroke can be administered safely (<10 percentage points higher risk of myotoxicity and/or hepatotoxicity). To assess efficacy of lovastatin administered at high doses.
Read More →Trial Milestones
The following dates are available for this trial. Trial information last updated on 5 May 2009.
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Trial Basics
Interventions
Sponsors
- The National Institute of Neurological Disorders and Stroke (NINDS) 1 P50 NS049060
Trial Design
Interventional, randomized, blinded and controlled safety study.
Contacts
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Tania E. Corporan, MD Columbia University Medical Center New York, NY 10032 Ph: 212-305-7755
tcorporan@neuro.columbia.edu
Recruitment
- Gender: Both
- Minimum Age: 18
- Study Size Planned: 130
- Number of Centers Planned: 2
- Max Time from Onset: 24 Hours
Principal Investigator
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Mitchell S. V. Elkind, MD, MS
Mitchell S. V. Elkind, MD, MS Associate Professor of Neurology Columbia University College of Physicians and Surgeons Phonr: 212 305-1710 Ying-Kuen Kenneth Cheung, PhD Statistician; Phone: 212 305-3332 J. Thomas Bigger, Jr., MD Chair, DSMB; Phone: 212 305-5058 Robert B. MacArthur, Pharm. D. Co-Investigator, Pharmacist; Phone:212 305-5068 Dana Leifer, MD; Co-Investigator
Locations
- Columbia University Medical Center, New York, NY Weill Cornell Medical Center, New York, NY