|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Columbia University |
|---|---|
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00243880 |
Purpose
The purpose of this dose escalation study is to evaluate the use of lovastatin for the treatment of acute ischemic stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Drug: lovastatin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Official Title: | SPOTRIAS: Neuroprotection With Statin Therapy for Acute Recovery Trial |
| Estimated Enrollment: | 33 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | May 2009 |
| Arms | Assigned Interventions |
|---|---|
|
1
lovastatin
|
Drug: lovastatin
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Mitchell Elkind, MD, MS | Columbia University |
| Principal Investigator: | Ji Chong, MD | Columbia University |
More Information
| Study ID Numbers: | R01NS049060 |
| Study First Received: | October 24, 2005 |
| Last Updated: | May 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00243880 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
|
acute ischemic stroke lovastatin statin neuroprotection SPOTRIAS |
|
Antimetabolites Molecular Mechanisms of Pharmacological Action Antilipemic Agents Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors |
Anticholesteremic Agents Brain Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Cerebrovascular Disorders Pharmacologic Actions Therapeutic Uses Cardiovascular Diseases Lovastatin |