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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
 Drug: Extended-Release Niacin
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Double-Blinded, Placebo-Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 28
Study Start Date: April 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Niaspan® 500mg Drug: Extended-Release Niacin
500mg tablet once daily
Other Name: Niaspan®
Experimental: Niaspan® 1000mg Drug: Extended-Release Niacin
1000mg tablet once daily
Other Name: Niaspan®
Placebo Comparator: Placebo Drug: Placebo
Placebo tablet once daily
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796887

Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Andrew N. Russman, D.O. Henry Ford Hospital
  More Information

Additional Information:
Henry Ford Hospital, Stroke and Neurovascular Diseases Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Andrew N. Russman, Senior Staff Neurologist, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00796887     History of Changes
Other Study ID Numbers: HFHS-5284
Study First Received: November 21, 2008
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Ischemic Stroke
Recovery of Function
Extended-release niacin

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Niacin
Nicotinic Acids
 Niacinamide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013