What is a clinical trial?

Clinical trials are health-related or bio-medical research studies that follow a pre-defined protocol and involve human beings.

Stoke patients are being recruited below for three current studies. Click the links to learn more about each study.

Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial

The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks and other complications in patients who have just had a TIA or minor ischemic stroke.

POINT is a randomized, double-blind, multicenter clinical trial to determine whether clopidogrel 75mg/day is effective in improving survival free from major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours time last known free of new ischemic symptoms of TIA or minor ischemic stroke in subjects receiving aspirin 50-325mg/day.

Learn more about Point.

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL – 130 mg/dL) will be safe and result in improved 3 month outcome after stroke.

Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study will evaluate the safety and efficacy of targeted glucose control (treatment group – IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The primary outcome will be functional outcome at 3 months as measured by the modified Rankin Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40 mg/dL. Enrollment will occur over 3.5 – 4 years.

Learn more about SHINE.

ACTIsSIMA

Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke (ACTIsSIMA)

ACTIsSIMA is a multicenter, randomized, controlled trial of clinical trial of 156 patients that will include approximately 65 sites. The study is being conducted to determine the safety and efficacy of a cell suspension of SB623 cells (modified stem cells) administered by one time injection into the brain around the area of the stroke. Eligible subjects must have had an ischemic stroke that happened at least 6 months ago but not more than 90 months ago and chronic motor deficits.

Learn more about ACTIsSIM.

Quantifying MicroRNA Levels in Ischemic Stroke

The purpose of this WVU study is to measure a small component in the blood called microRNA in patients diagnosed with stroke. MicroRNA are small non-coding sections of the genetic makeup of the body (the genome) that can regulate protein translation. Everyone has these microRNA in the body but previous research has found that some people with certain conditions have different levels compared to healthy individuals. There are 9 microRNA types we will to look at that are associated with how the body produces energy and how well the immune system works. Based on previous research findings, we believe that measuring these microRNA levels across the stroke injury period can provide insight into the progression of the stroke, may be associated with functional prognosis, and possibly identify a new way to treat stroke. We also will assess leukocyte subsets to understand the role of the immune system in post-stroke recovery.