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Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Apr 30, 2027 → Mar 31, 2028
See other at-risk trials from First Affiliated Hospital of Wannan Medical College

Record History

  1. Primary completion pushed from Apr 30, 2027 to Mar 31, 2028
    • Recruitment opened
    • Study completion pushed from Nov 30, 2027 to Mar 31, 2028
    • Start date changed from estimate of Apr 1, 2026 to Jun 18, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07501533
Lead Sponsor First Affiliated Hospital of Wannan Medical College
Conditions
(from sponsor)		 Severe Stroke
Related terms Stroke
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov