Ischemic Stroke
Conditions
Keywords
Ischemic Stroke, Recovery of Function, Extended-release niacin
Brief 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.
Detailed description
The investigators are interested in extended-release niacin (Niaspan®) and its potential restorative role after ischemic stroke. At Henry Ford Hospital in Detroit, Michigan, extended-release niacin (Niaspan®) has been shown to improve the functional outcomes of rats when administered during the first two weeks after ischemic stroke onset. Such results are encouraging and warrant further investigation in humans. The specific aims of this study are to prospectively evaluate the use of extended-release niacin (Niaspan®) in a phase II clinical trial in patients with subacute ischemic stroke. The investigators will assess the safety and tolerability of Niaspan® and evaluate outcomes among treated patients at 24 weeks after ischemic stroke onset. This will be a randomized, double-blinded, placebo-controlled, safety, tolerability, and exploratory efficacy study of extended-release niacin (Niaspan®) in subacute ischemic stroke patients with both low HDL-C and normal HDL-C in cohort sizes of 16 patients. A total enrollment of 48 patients is planned. Patients who are between 72 hours and 7 days from stroke onset will receive Niaspan® 500mg, 1000mg, or placebo daily for a period of 24 weeks. Evaluation of potential safety and tolerability in subacute ischemic stroke patients will be made during the course of treatment and at formal visits at 6, 12, and 24 weeks. The primary safety measures will be death, recurrent stroke, myocardial infarction, and neurological worsening during treatment. Exploratory analysis will include functional outcomes on the NIHSS scores, modified Rankin scores, and Barthel indices at 24 weeks. The goal of this study is to improve the outcomes from ischemic stroke, using a safe and effective novel strategy of restoration, which has been translated from basic laboratory studies.
Interventions
500mg or 1000mg tablet once daily
DRUGPlacebo
Placebo tablet once daily
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events | 24 weeks | Analysis of the frequency and type of serious adverse events among patients in each study arm/group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Recovery | 24 weeks | Exploratory efficacy analysis of the differences in functional recovery between each study arm as measured using the National Institutes of Stroke Scale score. The National Institutes of Health Stroke Scale score is a 15-item neurological examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored on a 3- to 5-point scale, with 0 as normal, and there is an allowance for untestable items. Scores range from 0 to 42, with higher scores indicating greater severity |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrew N. Russman, D.O.
Henry Ford Hospital
Participant flow
Pre-assignment details
Due to early termination of the study, participant enrollment in each extended-release niacin arm were lower than anticipated. T
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| National Institutes of Health Stroke Scale score | 10.4 scores on a scale STANDARD_DEVIATION 6.8 |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 10 | 1 / 7 | 1 / 10 |
| other Total, other adverse events | 2 / 10 | 1 / 7 | 1 / 10 |
| serious Total, serious adverse events | 2 / 10 | 1 / 7 | 1 / 10 |
Outcome results
None listed