Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)
The purpose of the CREST study is to compare the results of treating blockages in the carotid arteries with either carotid artery surgery (Endarteroctomy) or carotid artery stenting. Patients enrolled in CREST were assigned by chance to one of the treatments. We compared the risks and benefits of the two treatments in preventing stroke. Both of the treatments were selected because they are often used by doctors when treating patients who are at risk of stroke and because it was uncertain which treatment was better. The study is currently not enrolling. Patients are still being followed with a hospital visit for a carotid ultrasound as well as labs. The patient also receives a phone call from the research team once a year.
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy (CANOPY)
The purpose of this study is to evaluate the continued safety and effectiveness of the Acculink Carotid Artery Stent System, used in conjunction with the Accunet Embolic Protection Device during commercial use in the USA. The study is being conducted solely to collect information on medical condition related to the stent(s) patients have received. The study is currently not enrolling. Patient follow-up happens once a year for 3 years
Insulin Resistance Intervention after Stroke (IRIS) Trial
IRIS is testing the effectiveness of lowering insulin resistance with pioglitazone, compared with placebo, for prevention of recurrent stroke and myocardial infarction in non-diabetic patients with cerebrovascular disease and insulin resistance. The study is currently not enrolling (in follow-up phase). Patients have an annual clinic visit in addition to two follow-up phone visits a year.
The Intravascular Cooling in the Treatment of Stroke 2/3 (ICTuS 2/3) Trial
The purpose of this study is to determine whether the combination of thrombolysis and hypothermia issuperior to thrombolysis alone for the treatment of acute ischemic stroke.The study will be conducted in two stages: a Phase 2 study to assess the safety of various protocol changes, to demonstrate sufficient recruitment, and to allow an interim analysis for futility; and a Phase 3 efficacy study tofollow if pre-specified milestones are achieved. The study is currently enrolling and patients are followed for 90 days.
ACTION: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) on Reducing Infarct Volume in Acute Ischemic Stroke
Natalizumab is an antibody – a protein that affects the immune system. It is approved in the United States (US) and in many other countries for the treatment of relapsing multiple sclerosis (MS).It is also approved for the treatment of Crohn’s disease (CD) in the United States.
The primary purpose of this research study is to find out if an experimental medicine called natalizumab may reduce the size of strokes in people with acute ischemic stroke. In addition to the standard of care, patients will be randomly assigned to receive either 1 dose of intravenous (IV) natalizumab or one dose of IV placebo. The study is currently enrolling patients. Once enrolled in the study, patients are followed for 90 days.
PRISMS: A Phase IIIB, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients with Mild Stroke (Rapidly Improving Symptoms and Minor Neurologic Deficits)
The primary objective of this study is to determine the efficacy of intravenous (IV) alteplase for treatment of acute ischemic stroke (AIS) in patients with mild stroke (also known as “minor neurologic deficit” and “rapidly improving stroke symptoms”), defined as a National Institutes of
Health Stroke Scale (NIHSS) score ≤ 5 and not clearly disabling, within 3 hours of last known well time as measured by the proportion of patients with a modified Rankin Scale (mRS) 0-1 at Day 90
Irfan Altafullah, M.D.
Hija Mwadini 763-581-2993
Louis Thao 763-581-2994