NCT07501533

Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke

Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke: A Prospective, Randomized, Controlled, Open-Label, Blinded-Endpoint Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital of Wannan Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a exploratory, randomized, controlled, open-label, blinded-endpoint Phase II clinical trial designed to evaluate whether delaying antihyperglycemic treatment for 72 hours improves neurological outcomes in patients with severe stroke and hyperglycemia. A total of 426 patients with severe stroke (including ischemic stroke, intracerebral hemorrhage, or aneurysmal subarachnoid hemorrhage) within 24 hours of onset and blood glucose \>10 mmol/L at randomization will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either delayed antihyperglycemic treatment (initiated on Day 4) or early antihyperglycemic treatment (initiated on Day 1). Glycemic control targets (7.8-10.0 mmol/L) and insulin therapy follow current clinical guidelines. The primary outcome is the incidence of poor functional outcome (modified Rankin Scale score ≥ 3) at 90 days. Secondary outcomes include mortality, NIHSS score, GCS score, ICU length of stay, and safety events such as hypoglycemia and infections. The study aims to provide evidence on the optimal timing of glycemic control in severe stroke patients with stress hyperglycemia.

Conditions

• Severe Stroke

Interventions

Type	Name	Description
DRUG	Intravenous insulin	Insulin administered intravenously to maintain blood glucose between 7.8-10.0 mmol/L. Timing of initiation differs by arm: Day 1 for early group, Day 4 for delayed group.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-30
• Completion: 2027-11-30
• First posted: 2026-03-30
• Last updated: 2026-03-30