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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Ford Health System
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

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).

Imaging Related

• Evidence of primary intra-parenchymal hemorrhage on initial neuroimaging study.

• Neuroimaging evidence of a nonvascular cause for the neurological symptoms.