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

Primary Purpose

Ischemic Stroke

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Extended-Release Niacin

Placebo

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, Recovery of Function, Extended-release niacin

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Niaspan® 500mg

Niaspan® 1000mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of expected serious adverse events

Analysis of the frequency and type of serious adverse events among patients in each study arm

Secondary Outcome Measures

Functional Recovery

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.

Full Information

NCT ID

NCT00796887

First Posted

November 21, 2008

Last Updated

September 12, 2012

Sponsor

Henry Ford Health System

1. Study Identification

Unique Protocol Identification Number

NCT00796887

Brief Title

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

Official Title

Phase II, Randomized, Double-Blinded, Placebo-Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henry Ford Health System

4. Oversight

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

Ischemic Stroke, Recovery of Function, Extended-release niacin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Niaspan® 500mg

Arm Type

Experimental

Arm Title

Niaspan® 1000mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Extended-Release Niacin

Other Intervention Name(s)

Niaspan®

Intervention Description

500mg tablet once daily

Intervention Type

Drug

Intervention Name(s)

Extended-Release Niacin

Other Intervention Name(s)

Niaspan®

Intervention Description

1000mg tablet once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablet once daily

Primary Outcome Measure Information:

Title

Number of expected serious adverse events

Description

Analysis of the frequency and type of serious adverse events among patients in each study arm

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Functional Recovery

Description

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.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew N. Russman, D.O.

Organizational Affiliation

Henry Ford Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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