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


Phase 2 Results N/A

Eligibility 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

- 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.