Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
Aims: The objective of this study is to evaluate the safety and efficacy of DM199 in treating patients presenting with Acute Ischemic Stroke (AIS). The study evaluates rates of both Recovery and Recurrent AIS in subjects for whom thrombolysis and/or a catheter-based procedure, (e.g., mechanical thrombectomy (MT)), are not medically appropriate or available due to constraints of clot location, comorbidity risks, and/or time from estimated onset of stroke. Eligible subjects presenting with AIS will be randomized 1:1 to placebo or DM199 administered by a single intravenous (IV) dose followed by a subcutaneous (SC) dose within 12 hours and then SC doses 2 times per week until Day 21. The duration of subject participation in the study is 90 days.
Principal Investigator: Zachary Bulwa, MD
NorthShore Project Number: EH22-097
Contact: Call 847.570.2025 with questions regarding the study
Open to enrollment: Yes
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)
Aims: The purpose of this randomized trial is to determine if the incidence of stroke or death differs between subjects with high-grade asymptomatic carotid stenosis who receive intensive medical management alone, as compared to subjects who receive intensive medical management in combination with carotid artery stenting (CAS). The primary endpoint is stroke or death within 44 days after randomization or ipsilateral ischemic stroke thereafter, up to the 4-year follow-up time point.
Principal Investigator: William Ares, MD
NorthShore Project Number: EH22-019
Contact: Call 847.570.4224 with questions regarding this study.
Open to enrollment: Yes
Non-blinded Data Collection Pilot Study of Acute Stroke Using the BRAINPULSE™
Aims: The purpose of this pilot study is to collect data from patients experiencing stroke using the BrainPulse device. In the 2nd (current) phase of the study, data will be collected on two groups of patients: Those with Large Vessel Occlusion (LVO) acute stroke and non-LVO acute stroke. The data collected from the BrainPulse will be compared across these study groups in an attempt to distinguish stroke from other non-stroke conditions that present with similar symptoms and LVO from non-LVO types of strokes. Further assessments will also be made to evaluate if the BrainPulse can identify the presence of stroke.
Principal Investigator: Shakeel Chowdhry, MD
NorthShore Project Number: EH19-084
Contact: Call 847.570.4224 with questions regarding the study
Open to enrollment: Yes