Neuroprotection With Statin Therapy for Acute Recovery Trial (Neu-START) — Neu-START  

Stroke Clinical Trial

Official title: SPOTRIAS: Neuroprotection With Statin Therapy for Acute Recovery Trial

Status Completed

Clinical Trial Summary

The purpose of this dose escalation study is to evaluate the use of lovastatin for the treatment of acute ischemic stroke.

Clinical Trial Description

The Neuroprotection with Statin Therapy for Acute Recovery Trial (Neu-START) is part of the Specialized Program on Translational Research in Acute Stroke (SPOTRIAS). The overall goals of SPOTRIAS are to enhance delivery of acute stroke patient care with a focus on high-risk, disadvantaged populations, train acute stroke translational researchers, and conduct 3 innovative acute stroke projects.

Neu-START will enroll 33 patients with acute ischemic stroke presenting within 24 hours of onset. In the trial, investigators will treat the patients within 24 hours of symptom onset with short term high-dose lovastatin at escalating dosage. The escalating dosage levels will be 1, 3, 6, 8, and 10 mg/kg per day for 3 days. Lovastatin is in a class of drugs called statins, used for lowering cholesterol and preventing cardiovascular disease. Patients will be followed for 30 days for clinical and laboratory outcome events.

The goals of this trial are to determine if lovastatin in increasing doses from 1 mg/kg to 10 mg/kg daily for 3 days beginning 24 hours after acute ischemic stroke can be administered safely, and to assess the pharmacokinetics of lovastatin administered at high doses. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT00243880
• Study type: Interventional
• Source: Columbia University
• Status: Completed
• Phase: Phase 1
• Start date: September 2005
• Completion date: May 2008