Glyburide Advantage in Malignant Edema and Stroke Pilot

Exclusion Criteria

• •Evidence from imaging or pre-enrollment investigation of any diagnosis other than acute ischemic stroke likely to cause the presenting symptoms and signs.
• •Commitment to decompressive craniectomy (DC) prior to enrollment, or follow-ing enrollment and prior to start of study compound.
• •Treatment with IA rtPA or by mechanical means for clot disruption or with hypo-thermia.
• •Patients unable to tolerate MRI scanning, e.g. those with pacemakers or automatic defibrillators.
• •Pre-morbid mRS ≥ 2.
• •Clinical signs of herniation, e.g. one or two dilated, fixed pupils; unconsciousness (i.e., ≥ 2 on item 1a on the NIHSS); loss of other brain stem reflexes attributable to herniation according to the investigator's judgment.
• •CT or MRI evidence of hemorrhage or anteroseptal/pineal shift greater ≥2 mm prior to enrollment.
• •Rapidly improving symptoms.
• •Severe renal disorder from the patient's history (e.g. dialysis) or eGFR of \< 30 mL/min/1.73 m2.
• •Severe liver disease or ALT, AST, or bilirubin \>2 times normal.
• •Blood glucose \<55 mg/dL at enrollment or immediately prior to administration of RP-1127, or a clinically significant history of hypoglycemia.
• •Diagnosis of decompensated heart failure (e.g. clinical diagnosis of pulmonary edema, chest x-ray consistent with heart failure, tachypnea \> 20, etc.)
• •Sulfonylurea treatment within 30 days.
• •Known allergy to sulfa or specific allergy to sulfonylurea drugs.
• •Known G6PD enzyme deficiency.
• •Pregnancy or breast-feeding. Women must be either post-menopausal (judged by the investigator), permanently sterilized or, if of childbearing age, must have a negative test for pregnancy obtained before enrollment.
• •Patients already enrolled in a non-observation-only stroke study, or with life-expectancy \<3 months not related to current stroke, or those unlikely to be com-pliant with follow up.
• •Patients who, in the opinion of the investigator, are not suitable for the study (reason to be documented).