Neuroprotection With Statin Therapy for Acute Recovery Trial (Neu-START) (Neu-START)
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|ClinicalTrials.gov Identifier: NCT00243880|
Recruitment Status : Completed
First Posted : October 25, 2005
Last Update Posted : May 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: lovastatin||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SPOTRIAS: Neuroprotection With Statin Therapy for Acute Recovery Trial|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
lovastatin at escalating dosages: 1 mg/kg/day, 3 mg/kg/day, 6 mg/kg/day, 8 mg/kg/day, 10 mg/kg/day
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.
Other Name: Mevacor
- safety through 30 days defined as absence of liver or muscle-related toxicity on days 1, 2, 3, 5, 7, and 30. [ Time Frame: 30 days ]Devt of clinical or laboratory evidence of major hepatic or muscle toxicity. Either: (1) liver toxicity: liver function test increase, devt jaundice, unexplained coagulopathy, or other clinical evidence of hepatitis or liver failure; or (2) muscle toxicity: increase in creatine phosphokinase (CK) at any time point
- pharmacokinetic measurements made on days 1, 3, 4, and 5. [ Time Frame: 5 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243880
|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|