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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrew N. Russman, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00796887
First received: November 21, 2008
Last updated: September 12, 2012
Last verified: September 2012

November 21, 2008
September 12, 2012
April 2009
August 2012   (final data collection date for primary outcome measure)
Number of expected serious adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Analysis of the frequency and type of serious adverse events among patients in each study arm
Number of expected serious adverse events [ Time Frame: 6, 12, and 24 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00796887 on ClinicalTrials.gov Archive Site
Functional Recovery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Exploratory efficacy analysis of the differences in functional recovery between each study arm as measured using the modified Rankin Scale, NIH Stroke Scale, and Barthel Index.
  • Change in modified Rankin score, compared to enrollment [ Time Frame: 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
  • Change in NIH Stroke Scale Score, compared to enrollment [ Time Frame: 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
  • NIH Stroke Scale Scores <2 [ Time Frame: 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
  • Barthel index >80 [ Time Frame: 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery
Phase II, Randomized, Double-Blinded, Placebo-Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
  • Drug: Extended-Release Niacin
    500mg tablet once daily
    Other Name: Niaspan®
  • Drug: Extended-Release Niacin
    1000mg tablet once daily
    Other Name: Niaspan®
  • Drug: Placebo
    Placebo tablet once daily
    Other Name: Placebo
  • Experimental: Niaspan® 500mg
    Intervention: Drug: Extended-Release Niacin
  • Experimental: Niaspan® 1000mg
    Intervention: Drug: Extended-Release Niacin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00796887
HFHS-5284
Yes
Andrew N. Russman, Henry Ford Health System
Henry Ford Health System
Not Provided
Principal Investigator: Andrew N. Russman, D.O. Henry Ford Hospital
Henry Ford Health System
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP