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NCT Number: NCT07501533

Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke

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.

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Key information

Conditions

Severe Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • 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

  • Known history of type 1 diabetes mellitus;
  • Known allergy to insulin or diagnosis of insulinoma;
  • Pre-stroke modified Rankin Scale (mRS) score > 1;
  • Hemodynamic instability refractory to medical treatment (systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg);
  • Decompensated heart failure (New York Heart Association [NYHA] class III or IV);
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min;
  • Expected survival < 90 days due to malignancy;
  • Participation in another drug or device clinical trial within the past 30 days;
  • Women of childbearing potential who refuse to use effective contraception despite negative pregnancy test, pregnant women, or breastfeeding women.

Treatment and study plan

Intravenous insulin

Drug

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.

Primary outcomes

  1. Poor Functional Outcome at 90 Days

    Time frame: from enrollment to day 90 post-enrollment

    Proportion of patients with modified Rankin Scale (mRS) score ≥ 3, assessed at 90 days post-randomization. The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death).

Secondary outcomes

  1. All-cause Mortality at ICU Discharge or Day 14

    Time frame: from admission to ICU discharge within 14 days

    Proportion of patients who die from any cause by ICU discharge or Day 14, whichever occurs first

  2. Neurological Status at ICU Discharge or Day 14

    Time frame: from admission to ICU discharge within 14 days

    Neurological function assessed by National Institutes of Health Stroke Scale (NIHSS) score. NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological deficits

  3. Level of Consciousness at ICU Discharge or Day 14

    Time frame: from admission to ICU discharge within 14 days

    Level of consciousness assessed by Glasgow Coma Scale (GCS) score. GCS ranges from 3 to 15, with lower scores indicating impaired consciousness

  4. All-cause Mortality at 90 Days

    Time frame: from admission to discharge at 90 days

    Proportion of patients who die from any cause within 90 days post-randomization

  5. Length of ICU Stay

    Time frame: From admission to ICU discharge, an average of 11 days

    Total duration of intensive care unit (ICU) hospitalization, measured in days

  6. Incidence of Adverse Events

    Time frame: From randomization to ICU discharge or Day 14, whichever occurs first

    Proportion of patients experiencing adverse events during ICU stay, including hypoglycemia (random blood glucose < 3.3 mmol/L), symptomatic hypoglycemia, pulmonary infection, urinary tract infection, and electrolyte disturbances

  7. Incidence of Serious Adverse Events

    Time frame: From randomization to 90 day post-randomization

    Proportion of patients experiencing serious adverse events, defined as any event resulting in death, disability, congenital anomaly, or severe hypoglycemia (random blood glucose < 2.22 mmol/L) requiring prolonged hospitalization or re-admission

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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