Intensive Insulin Therapy With Tight Glycemic Control to Improve Outcomes After Endovascular Therapy for Acute Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and efficacy of lowering glucose (blood
      sugar), in addition to endovascular therapy, after acute ischemic stroke. The study will
      determine if lowering glucose (blood sugar) in addition to endovascular therapy will improve
      90-day functional and neurological outcomes in comparison to standard glycemic care in
      patients with acute ischemic stroke. The study will involve treatment of 100 (50 intensive
      insulin therapy and 50 standard glycemic control) non-diabetic patients presenting within 8
      hours of acute ischemic stroke who have undergone endovascular therapy.
    

Detailed description: 
      This will be a prospective open label study of 100 subjects who will be randomized to either
      an insulin aspart (study drug) infusion (intensive insulin therapy [IIT arm]) for 48hrs or to
      a control arm. All patients attending the emergency department (ED) of Kaleida health within
      24 hrs of symptom onset suggestive of an anterior circulation ischemic stroke will be
      screened. If they meet the inclusion criteria and do not have any exclusion criteria,
      informed consent will be obtained and a blinded stratified block randomization process will
      be initiated.

      In addition to receiving endovascular and standard medical therapy for AIS, subjects will be
      randomized to an intensive insulin treatment arm (IIT arm) or control arm. In the IIT arm
      subjects will receive an insulin aspart infusion at a minimal rate of 2 units/hr while
      maintaining blood glucose between 90-120mg/dl for 48 hrs. Glucose control in the control will
      be at the discretion of the treating provider.

      Subjects will have the following study procedures done at different time points: A)
      assessment of neurological outcomes : modified Rankin scale (mRS) at 30 days and 90 days and
      NIH stroke scale (NIHSS) at baseline , 24 hrs, 72 hrs, 30 days and 90 days.

      B) MRI (Diffusion weighted imaging), 3-5 days and 90 days and C) various plasma and cellular
      endpoints will be measured in blood collected at baseline, 2, 4, 6, 24 , 48 and 72 hrs and at
      30 days and 90 days.

      The primary endpoint of the study is to detect a difference in the percentage of non diabetic
      subjects with mRS 0-2 at 90 days after an AIS treated with endovascular therapy, in the IIT
      and control arm.
    

Intervention name(s): Insulin
Intervention type(s): Drug
Intervention description(s): Intensive Insulin Therapy (IIT) will be given to you by two IV infusions. The insulin infusion will be started immediately after you are moved to the intensive care unit (ICU) after endovascular therapy and continued for 48 hours
Other intervention name(s): insulin and; dextrose/ potassium
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment