Our Institute has a long history of implementing trials that we conceived at our center, going back to the 1980s when we developed neuroprotective agents for stroke. Over time, we have focused on designing new treatment approaches for acute stroke, brain hemorrhage, and stroke recovery. In acute stroke, we have developed several approaches to amplify t-PA’s effects (argatroban, ultrasound) and these approaches have gone forward to phase III clinical trials. In brain hemorrhage, we took forward work in our laboratories that the diabetic medication pioglitazone actually promotes hematoma reabsorption in ICH and then completed a phase 2 randomized trial demonstrating the safety of high doses of pioglitazone. In stroke recovery, we are the first center to take forward a cell-based therapy from animals to stroke patients in which bone marrow is aspirated from the patient and sorted cells are then given back to the patient as an intravenous autologous auto-transfusion.
Investigator Initiated Studies
Optimizing Patient’s Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT): PI Amrou Sarraj, MD
A multicenter, observational prospective study implementing a protocol to acquire imaging and clinical variables known to affect clinical outcomes after endovascular therapy in an effort to evaluate and compare the different selection methods and criteria currently used in practice for acute ischemic stroke patients in the anterior circulation with large vessel occlusion. The study aim is to evaluate prospectively different selection methodologies for endovascular therapy, to compare them against each other to identify which method provides the highest predictive ability in the selection of patients for IAT and to devise a formula that predicts patients’ outcomes.
Multi-Arm Optimization of Stroke Thrombolysis (MOST): PI Andrew Barreto, MD
A double-blinded multi-center, randomized controlled Phase 3 trial wish a maximum of 1200 subjects. The trial will determine if adult (age ≥18 years) subjects with an NIH stroke scale score ≥6 at baseline treated within three hours of symptom onset with rt-PA followed by argatroban or eptifibatide are more likely to have a favorable outcome at 3 months (mRS) as compared to subjects treated with standard IV rt-PA alone.
Sedation versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke (SEGA): PI Roc Chen, MD and Co-I Andrew Barreto, MD
The majority of strokes are the result of blood clots in the main vessels that provide blood to the brain. When people suffer from a stroke, these blood clots produce a blockage to the normal flow of blood, which can cause brain tissue to be damaged. This often produces symptoms such as weakness or numbness to one side of the body, changes in vision, or changes in people’s abilities to speak or be understood.
Although the body may break up the blood clots on its own, doctors also use a clot-busting drug called rt-PA for patients with certain types of stroke. Unfortunately, rt-PA is not always successful in breaking up clots. Larger clots can also be removed from the brain by performing an emergency surgery called endovascular therapy which can restore normal blood flow. Endovascular therapy with stent retrievers have been shown to improve outcomes in acute stroke patients. However, there is still some controversy about the best type of anesthesia – general anesthesia (GA) vs sedation (CS) to be used during endovascular therapy.
The purpose of this study is to study whether GA during endovascular therapy results in better outcomes compared with CS during endovascular therapy among acute ischemic stroke patients.
Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage (SHRINC): PI Nicole Gonzales, MD
Intracerebral hemorrhage (ICH) is a devastating disease with less than 20% of survivors being independent at 6 months. There is currently no approved treatment for ICH which has been shown to improve outcomes. In an effort to develop a new treatment for ICH, this research focuses on a different aspect of ICH treatment which has not yet been evaluated: enhancing absorption of the blood clot with medication. We completed a Phase II dose escalation trial, the results of which are currently being analyzed.