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.
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.
Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke – Enhanced Regimen (CLEAR-ER)
The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke – Enhanced Regimen (CLEAR-ER) is an NIH funded, multicenter, randomized, double-blind trial to determine the safety of the combination of medium dose rt-PA (0.6 mg/kg total) plus eptifibatide (bolus 135 mcg/kg and 2 hour infusion at 0.75 mcg/kg/min) compared to standard dose rt-PA (0.9 mg/kg) in patients with acute ischemic stroke that can have the rt-PA initiated within 3 hours of symptom onset.
The primary safety outcome measure will be symptomatic ICH within 36 hours of initiation of therapy. The primary efficacy outcome measure is the modified Rankin Scale score Ã¢â€°¤1 or return to mRS baseline at 90 days.
To be eligible, patients must have an acute ischemic stroke and must have treatment initiated within 3 hours of symptom onset. Additionally patients must be 18-85 years of age and have an NIH Stroke Scale >5. In total, 126 patients from 9 centers are projected to be randomized in this trial.
Learn more about clinical trials at the U.S. National Institutes of Health.