I-SPOT
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.
Key Findings
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.
Detailed Results
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.
Background
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
References:
- 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)
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