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/A

Trial Description

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.

Interventions

  • Lovastatin (Mevacor)Drug
    Other Names: Mevacor
    Intervention Desc: 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor; lowers cholesterol
  • Placebo Drug
    Intervention Desc: A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.

Trial Design

Interventional, randomized, blinded and controlled safety study.

Patient Involvement

Patients will be randomized to either (1) placebo or (for those already on statins) standard dose lovastatin 80 mg daily) versus (2) short-term high-dose lovastatin 640 mg per day for 3 days. Patients will be followed for 90 days for clinical outcome events and laboratory tests.

Outcomes

Type Measure Time Frame Safety Issue
Primary Musculoskeletal and hepatic toxicity, defined by clinical and laboratory criteria, with a 3 month follow-up period.
Secondary Neurological outcome (NIH Stroke Scale), functional outcomes (Barthel Index), and handicap (modified Rankin scores). Effects on inflammatory markers, lipid levels, and coagulation effects wll also be assessed.

Sponsors

The National Institute of Neurological Disorders and Stroke (NINDS) 1 P50 NS049060