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Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke

RecruitingPhase 2Ages 18 Years - anyAllFirst Affiliated Hospital of Wannan Medical Colle…
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In plain words

What the trial is, and whether it could suit you

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 outcome

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 18 years; 2. Severe stroke within 24 hours of onset, meeting one of the following criteria: 1)Severe ischemic stroke: Glasgow Coma Scale (GCS) score ≤ 12 or National Institutes of Health Stroke Scale (NIHSS) score ≥ 15 or CT hypodensity \> 1/3 of middle cerebral artery (MCA) territory; 2)Severe intracerebral hemorrhage: Supratentorial hematoma volume ≥ 30 mL (thalamic hemorrhage ≥ 10 mL) or infratentorial hematoma volume ≥ 10 mL (brainstem hemorrhage ≥ 5 mL); 3)Aneurysmal subarachnoid hemorrhage; 3. Blood glucose level \> 10 mmol/L at randomization; 4. Signed informed consent. Exclusion Criteria: 1. Known history of type 1 diabetes mellitus; 2. Known allergy to insulin or diagnosis of insulinoma; 3. Pre-stroke modified Rankin Scale (mRS) score \> 1; 4. Hemodynamic instability refractory to medical treatment (systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg); 5. Decompensated heart failure (New York Heart Association \[NYHA\] class III or IV); 6. Estimated glomerular filtration rate (eGFR) \< 30 mL/min; 7. Expected survival \< 90 days due to malignancy; 8. Participation in another drug or device clinical trial within the past 30 days; 9. Women of childbearing potential who refuse to use effective contraception despite negative pregnancy test, pregnant women, or breastfeeding women.
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What it tests

  • Intravenous insulin
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Where

1 site
The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)
Wuhu, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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