Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243880
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2005-10-24
Brief Title:
Neuroprotection With Statin Therapy for Acute Recovery Trial Neu-START
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
SPOTRIAS Neuroprotection With Statin Therapy for Acute Recovery Trial
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Neu-START
Brief Summary:
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 mgkg 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 mgkg to 10 mgkg 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
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 mgkg 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 mgkg to 10 mgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS049060 | OTHER_GRANT | NIH | None |