Clinical Trial Details
Study of Procoagulation Markers in Stroke Patients (I-SPOT)
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.
Efficacy and safety of intensive vs. standard hyperglycemia control; functional neurological outcomes are examined for increased tissue marker levels after treatment that are associated with clotting in AIS patients with T2DM.
Purpose: To evaluate the safety and efficacy of intensive vs standard glucose control on coagulation markers and functional neurological outcomes in AIS patients with hyperglycemia.
Trial Design: An ancillary trial to the Stroke Hyperglycemia Insulin Network Effort (SHINE); randomized, controlled, multicenter trial. N=270; 34 sites in the US. Comparison of efficacy and safety of intensive glucose control (target 80 mg/dL - 130 mg/dL) to standard control (target up to 179 mg/dL) for functional neurological outcomes by comparing coagulation markers.
Primary Endpoints: Change in blood coagulation marker levels from baseline to 48 hours.
|Changes in markers and favorable functional outcome|
|Intensive glucose control||Reduced TF-PCA and FVIII; increased FvIIa.
With no tPA, FvIIa elevated when outcomes were favorable.
|Standard glucose control||Increased FBII only|
Results: Intensive glucose control was associated with reduced tissue factor procoagulation.
Trial Design: An ancillary trial to the Stroke Hyperglycemia Insulin Network Effort (SHINE).
- Observational, prospective cohort.
- Randomized, controlled, multicenter trial.
- N=270; 34 sites in the US.
- Comparison of efficacy and safety of intensive glucose control (target 80 mg/dL - 130 mg/dL) to standard control (target up to 179 mg/dL) for functional neurological outcomes by comparing coagulation markers.
Trial population: 270 SHINE patients with hyperglycemia and AIS.
Primary endpoints: Change in biomarker between for favorable vs unfavorable functional outcome @ 48 hours and 90 days.
Key Words Large core, intracerebral hemorrhage, stroke endovascular thrombectomy
Related Clinical Topics: Stroke, intracerebral hemorrhage, rehabilitation, functional outcome, ischemic stroke, modified Rankin Scale, surgery
Sponsors and collaborators:
- Sponsor: Temple University
- Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Neurological Emergencies Treatment Trials Network (NETT), University of Virginia, University of Michigan, Medical University of South Carolina, Augusta University
- Presented by: Nina T. Gentile at the International Stroke Conference 2019 in Honolulu, Hawaii
- Clinicaltrials.gov/ NCT01811550
- Gentile's Abstract
- Gentile's Presentation Slides (PDF)
- SHINE Trial
- Abstract TP145: Admission Hyperglycemia Predicts Poor Cerebral Collateral Flow in Acute Ischemic Stroke