Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke

First Affiliated Hospital of Wannan Medical College

Status and phase: Not yet enrolling; Phase 2

Conditions: Severe Stroke

Treatments: Drug: Intravenous insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT07501533

202603

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Delayed Antihyperglycemic Group

Experimental group

Description:

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.

Treatment:

Drug: Intravenous insulin

Early Antihyperglycemic Group

Active Comparator group

Description:

Antihyperglycemic treatment is initiated on Day 1. Insulin therapy targets blood glucose 7.8-10.0 mmol/L until ICU discharge or Day 14.

Treatment:

Drug: Intravenous insulin