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
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2008
CompletedFirst Posted
Study publicly available on registry
November 24, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedSeptember 14, 2012
September 1, 2012
3.3 years
November 21, 2008
September 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of expected serious adverse events
Analysis of the frequency and type of serious adverse events among patients in each study arm
24 weeks
Secondary Outcomes (1)
Functional Recovery
24 weeks
Study Arms (3)
Niaspan® 500mg
EXPERIMENTALNiaspan® 1000mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry Ford Hospital
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew N. Russman, D.O.
Henry Ford Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Staff Neurologist
Study Record Dates
First Submitted
November 21, 2008
First Posted
November 24, 2008
Study Start
April 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
September 14, 2012
Record last verified: 2012-09