Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery

Completed · Phase 2 · Has a placebo group

Conditions studied: Ischemic Stroke

In brief

The purpose of this study is to determine the safety, tolerability, and to explore the possible benefit of extended-release niacin (Niaspan®) in attempting to improve the recovery of patients after ischemic stroke.

Key facts

Study ID

NCT00796887

Run by

Henry Ford Health System

People needed

28

Starts

2009-04-01

Expected to finish

2012-08-01

Last updated by the study team

2012-09-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with clinical ischemic stroke able to enroll between 72 hours and 7 days after symptom onset.
• Patients age 18-85, inclusive.
• NIHSS score of 4-21, inclusive, prior to treatment.
• Signed IRB-approved informed consent by patient or authorized representative.

You may not qualify if…

• General
• Participation in another study with an investigational drug or device.
• Women known to be pregnant, lactating, or of childbearing potential with a positive urine beta-HCG.
• Patients using niacin within the 7 days previous to their stroke.
• Safety Related
• Unstable angina.
• Acute Myocardial infarction.
• Concurrent arterial bleeding.
• Active peptic ulcer disease.
• Platelet count less than 100,000 per microliter.
• Internationally Normalized Ratio (INR) greater than 1.3 without use of warfarin.
• Concurrent use of bile acid sequestrants (colestipol and cholestyramine)
• Baseline systolic blood pressure less than 100 mmHg.
• History of significant hepatic dysfunction.
• Allergy or hypersensitivity to aspirin.
• Concurrent use of amiodarone, gemfibrozil, fibrate or other bile acid resin, cyclosporine, itraconazole, ketaconazole, telithromycin, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, danazol.
• Allergy or hypersensitivity to extended-release niacin.
• Allergy or hypersensitivity to statin agents.
• Potentially Interfering with Outcomes Assessment
• Prior history of dementia.
• Patients without fixed address or those deemed unlikely to present for follow-up by the investigator.
• Patients whose life expectancy is less than 24 weeks.
• Pre-stroke modified Rankin score>2.
• Glucose less than 50 mg/dl.
• Other serious illness (e.g., severe hepatic, cardiac, or renal failure; or a complex disease that may confound treatment assessment).

Where it is running

• Henry Ford Hospital — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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