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History of Changes for Study: NCT00796887
The Role of Dyslipidemia and Extended-Release Niacin in Stroke Recovery
Latest version (submitted September 12, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 21, 2008 None (earliest Version on record)
2 January 15, 2009 Recruitment Status, Study Status and Contacts/Locations
3 September 24, 2009 Contacts/Locations, Eligibility and Study Status
4 May 25, 2010 Study Status
5 July 15, 2011 Contacts/Locations, Outcome Measures, Study Status, Eligibility and Study Identification
6 July 19, 2011 Study Description and Study Status
7 September 12, 2012 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations and Study Design
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Study NCT00796887
Submitted Date:  November 21, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: HFHS-5284
Brief Title: The Role of Dyslipidemia and Extended-Release Niacin in Stroke Recovery
Official Title: Phase II, Randomized, Double-Blinded, Placebo-Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2008
Overall Status: Not yet recruiting
Study Start: January 2009
Primary Completion: December 2011 [Anticipated]
Study Completion: December 2011 [Anticipated]
First Submitted: November 21, 2008
First Submitted that
Met QC Criteria:
November 21, 2008
First Posted: November 24, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 21, 2008
Last Update Posted: November 24, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Henry Ford Health System
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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: We 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. We 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 6, 12, and 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 our basic laboratory studies.
Open or close this module Conditions
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
Recovery of Function
Extended-release niacin
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 48 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Niaspan® 500mg Drug: Extended-Release Niacin
500mg tablet once daily
Other Names:
  • Niaspan®
Experimental: Niaspan® 1000mg Drug: Extended-Release Niacin
1000mg tablet once daily
Other Names:
  • Niaspan®
Placebo Comparator: Placebo Drug: Placebo
Placebo tablet once daily
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of expected serious adverse events
[ Time Frame: 6, 12, and 24 weeks ]

Secondary Outcome Measures:
1. Change in modified Rankin score, compared to enrollment
[ Time Frame: 6, 12, and 24 weeks ]

2. Change in NIH Stroke Scale Score, compared to enrollment
[ Time Frame: 6, 12, and 24 weeks ]

3. NIH Stroke Scale Scores <2
[ Time Frame: 6, 12, and 24 weeks ]

4. Barthel index >80
[ Time Frame: 6, 12, and 24 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
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 18-80, inclusive.
  • NIHSS score of 4-20 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.
  • Unstable angina.
  • Myocardial infarction within 3 months.
  • Concurrent arterial bleeding.
  • Active peptic ulcer disease.
  • Platelet count less than 150,000 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.
  • Creatinine > 2.0 mg/dL.
  • Abnormal liver function studies or a history of hepatitis.
  • Patients with a history of gout.
  • 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, and verapamil.
  • Allergy or hypersensitivity to extended-release niacin.
  • Allergy or hypersensitivity to statin agents.
  • Unable to safely swallow pills (medication cannot be crushed or cut)
  • 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 greater less than 50 or greater than 400 mg/dL at presentation.
  • Other serious illness (e.g., severe hepatic, cardiac, or renal failure; acute myocardial infarction; or a complex disease that may confound treatment assessment).
  • Evidence of primary intra-parenchymal hemorrhage on initial neuroimaging study.
  • Neuroimaging evidence of a nonvascular cause for the neurological symptoms.
Open or close this module Contacts/Locations
Central Contact Person: Andrew N Russman, D.O.
Telephone: 313-916-9107
Email: russman@neuro.hfh.edu
Study Officials: Andrew N. Russman, D.O.
Principal Investigator
Henry Ford Hospital
Locations: United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Contact:Contact: Andrew N. Russman, D.O. 313-916-9107 russman@neuro.hfh.edu
Contact:Principal Investigator: Andrew N. Russman, D.O.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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