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Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke Phase 2 200 Randomized Open-Label

Not yet recruiting
Clinical Trial NCT07501533 is designed to study Treatment for Severe Stroke. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on April 1, 2026 until the study accrues 200 participants. Led by First Affiliated Hospital of Wannan Medical College, this study is expected to complete by November 30, 2027. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief 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 o...

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Official Title

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

Conditions
Severe Stroke
Other Study IDs
  • 202603
NCT ID Number
NCT07501533
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-11-30
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalDelayed Antihyperglycemic Group
Antihyperglycemic treatment is delayed for 72 hours after enrollment. Insulin therapy is initiated on Day 4 targeting blood glucose 7.8-10.0 mmol/L until ICU discharge or Day 14.
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.
Active ComparatorEarly Antihyperglycemic Group
Antihyperglycemic treatment is initiated on Day 1. Insulin therapy targets blood glucose 7.8-10.0 mmol/L until ICU discharge or Day 14.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Poor Functional Outcome at 90 Days
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).
from enrollment to day 90 post-enrollment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
All-cause Mortality at ICU Discharge or Day 14
Proportion of patients who die from any cause by ICU discharge or Day 14, whichever occurs first
from admission to ICU discharge within 14 days
Neurological Status at ICU Discharge or Day 14
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
from admission to ICU discharge within 14 days
Level of Consciousness at ICU Discharge or Day 14
Level of consciousness assessed by Glasgow Coma Scale (GCS) score. GCS ranges from 3 to 15, with lower scores indicating impaired consciousness
from admission to ICU discharge within 14 days
All-cause Mortality at 90 Days
Proportion of patients who die from any cause within 90 days post-randomization
from admission to discharge at 90 days
Length of ICU Stay
Total duration of intensive care unit (ICU) hospitalization, measured in days
From admission to ICU discharge, an average of 11 days
Incidence of Adverse Events
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
From randomization to ICU discharge or Day 14, whichever occurs first
Incidence of Serious Adverse Events
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
From randomization to 90 day post-randomization
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
First Affiliated Hospital of Wannan Medical College logoFirst Affiliated Hospital of Wannan Medical College
Study Responsible Party
Jie Xu, Principal Investigator, professor, First Affiliated Hospital of Wannan Medical College
No contact data.