Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00796887
Study type	Interventional
Source	Henry Ford Health System
Contact
Status	Completed
Phase	Phase 2
Start date	April 2009
Completion date	August 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05196659` - Collaborative Quality Improvement (C-QIP) Study	N/A
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Completed	`NCT03281590` - Stroke and Cerebrovascular Diseases Registry
Recruiting	`NCT05518305` - Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
Recruiting	`NCT06029959` - Stroke and CPAP Outcome Study 3	N/A
Recruiting	`NCT03728738` - Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke	Phase 3
Terminated	`NCT03396419` - IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Recruiting	`NCT05065216` - Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)	Phase 2/Phase 3
Recruiting	`NCT04897334` - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke	N/A
Not yet recruiting	`NCT06462599` - Osteopontin Gene Polymorphism in Stroke Patients in Egypt
Not yet recruiting	`NCT06026696` - Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
Not yet recruiting	`NCT06032819` - Differentiating Between Brain Hemorrhage and Contrast
Recruiting	`NCT02910180` - Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
Completed	`NCT02922452` - A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects	Phase 1
Withdrawn	`NCT01866189` - Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke	N/A
Completed	`NCT03554642` - Walkbot Robotic Training for Improvement in Gait	Phase 3
Recruiting	`NCT03041753` - Reperfusion Injury After Stroke Study	N/A
Completed	`NCT02549846` - AdminiStration of Statin On Acute Ischemic stRoke patienT Trial	Phase 4
Completed	`NCT01678534` - Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial	Phase 2
Completed	`NCT02610803` - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms