Intensive Insulin Therapy With Tight Glycemic Control to Improve Outcomes

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02054429
Study type	Interventional
Source	University at Buffalo
Contact
Status	Completed
Phase	Phase 1
Start date	January 2013
Completion date	December 31, 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Intensive Insulin Therapy With Tight Glycemic Control to Improve Outcomes After Endovascular Therapy for Acute Ischemic Stroke

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms