Study of Procoagulation Markers in Stroke Patients

The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT):
Response to Insulin Administration and Blood Glucose Control proposal is designed to
accompany the Stroke Hyperglycemia Insulin Network Effort (SHINE) clinical trial, a Phase III
multicenter, randomized, controlled trial planning to determine the efficacy and validate the
safety of glycemic control in stroke patients. The SHINE trial will recruit 1,400 AIS
patients with Type II diabetes mellitus (T2DM) and hyperglycemia, each receiving 3 days of
hyperglycemia control with intravenous (IV) insulin therapy or control therapy with
subcutaneous (SQ) insulin. The I-SPOT trial will recruit 315 SHINE patients. Blood
coagulation marker levels will be measured before and at 48 hours after the start of
treatment. Baseline and temporal changes in biomarkers levels will be compared between
treatment groups.

Hypothesis: The decrease in levels of markers of blood coagulation will be greater in
patients treated with IV insulin to reduce BG than in patients treated with SQ Insulin as the
standard fashion.

Hypothesis: The decrease in levels of markers of blood coagulation will be greater in
patients with than without favorable (SHINE) outcome (defined as the baseline stroke severity
adjusted measure of functional ability at 90 days after AIS).

Hypothesis: Hyperglycemia control modulates the relationship between blood coagulation levels
and functional outcome in T2DM patients after stroke. Patients treated with IV Insulin for
hyperglycemia control with favorable (SHINE) outcome will have greater decreases in blood
coagulation levels than either IV Insulin-treated patients without favorable outcome or SQ
Insulin-treated with or without favorable outcomes at 90 days after AIS.