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

Completed

Phase 1 Results

Trial Description

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

Detailed 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.

Conditions

Interventions

  • Lovastatin (Mevacor)Drug
    Other Names: Mevacor
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: 1
    Description: lovastatin
    ARM 2: Kind: Experimental
    Label: lovastatin
    Description: lovastatin at escalating dosages: 1 mg/kg/day, 3 mg/kg/day, 6 mg/kg/day, 8 mg/kg/day, 10 mg/kg/day

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Single Group Assignment

Patient Involvement

Escalating dosage levels of short-term high-dose oral lovastatin (1, 3, 6, 8 and 10 mg/kg per day for 3 days). Dose-toxicity model is calibrated such that the method will eventually select a dose that causes 7% to 13% dose-limiting toxicity.

Outcomes

Type Measure Time Frame Safety Issue
Primary Musculoskeletal and hepatic toxicity, defined by clinical and laboratory criteria, with a one-month follow-up period.
Secondary Other clinical and laboratory data, including platelet effects and pharmacokinetic parameters, will also be assessed.
Primary safety through 30 days defined as absence of liver or muscle-related toxicity on days 1, 2, 3, 5, 7, and 30. 30 days Yes
Secondary pharmacokinetic measurements made on days 1, 3, 4, and 5. 5 days

Sponsors