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

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ClinicalTrials.gov Identifier: NCT00796887
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : September 14, 2012
Sponsor:
Information provided by (Responsible Party):
Andrew N. Russman, Henry Ford Health System

Tracking Information
First Submitted Date  ICMJE November 21, 2008
First Posted Date  ICMJE November 24, 2008
Last Update Posted Date September 14, 2012
Study Start Date  ICMJE April 2009
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
Number of expected serious adverse events [ Time Frame: 24 weeks ]
Analysis of the frequency and type of serious adverse events among patients in each study arm
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
Number of expected serious adverse events [ Time Frame: 6, 12, and 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
Functional Recovery [ Time Frame: 24 weeks ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
  • Change in modified Rankin score, compared to enrollment [ Time Frame: 6, 12, and 24 weeks ]
  • Change in NIH Stroke Scale Score, compared to enrollment [ Time Frame: 6, 12, and 24 weeks ]
  • NIH Stroke Scale Scores <2 [ Time Frame: 6, 12, and 24 weeks ]
  • Barthel index >80 [ Time Frame: 6, 12, and 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery
Official Title  ICMJE Phase II, Randomized, Double-Blinded, Placebo-Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Niaspan® 500mg
    Intervention: Drug: Extended-Release Niacin
  • Experimental: Niaspan® 1000mg
    Intervention: Drug: Extended-Release Niacin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2012)
28
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2008)
48
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00796887
Other Study ID Numbers  ICMJE HFHS-5284
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Andrew N. Russman, Henry Ford Health System
Original Responsible Party Andrew N. Russman, D.O., Principal Investigator, Henry Ford Health System
Current Study Sponsor  ICMJE Henry Ford Health System
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew N. Russman, D.O. Henry Ford Hospital
PRS Account Henry Ford Health System
Verification Date September 2012

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