SLGT2i for Neuroprotection in Patients With Acute Ischemic Stroke

NCT ID: NCT07105917

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1050 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-11-01

Brief Summary

Stroke is a leading cause of disability and mortality globally. With population aging, ischemic stroke (80% of cases) has become China's primary cause of adult disability. Sodium-dependent glucose transporters 2 inhibitors （SGLT2i） demonstrate cardiovascular protection beyond glycemic control, even in patients without diabetes.

Preclinical studies suggest neuroprotective effects via improving cerebral glucose metabolism, anti-inflammatory/antioxidant actions, and reducing neuronal apoptosis. Therefore, the investigators aim to evaluate whether SGLT2i could improve 3-month functional outcomes (mRS scores) in AIS patients compared to standard care.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: SGLT2i with standard therapy

Any of the following SGLT2 inhibitors (SGLT2i) can be selected for treatment:

Dapagliflozin 10 mg once daily (QD) or Empagliflozin 10 mg once daily (QD) If the patient has concurrent diabetes, the use of other antidiabetic drugs is not restricted.

The treatment should last for at least 14 days.

Group Type: EXPERIMENTAL

SGLT-2 inhibitors

Intervention Type: DRUG

Any of the following SGLT2 inhibitors (SGLT2i) can be selected for treatment:

Dapagliflozin 10 mg once daily (QD) or Empagliflozin 10 mg once daily (QD) If the patient has concurrent diabetes, the use of other antidiabetic drugs is not restricted.

The treatment should last for at least 14 days.

Standard therapy

According to the guideline-recommended standard treatment, if the patient has diabetes, there is no restriction on the use of other antidiabetic drugs (except SGLT-2 inhibitors).

Group Type: SHAM_COMPARATOR

Standard medical treatment

Intervention Type: OTHER

According to the guideline-recommended standard treatment, if the patient has diabetes, there is no restriction on the use of other antidiabetic drugs (except SGLT-2 inhibitors).

Interventions

SGLT-2 inhibitors

Any of the following SGLT2 inhibitors (SGLT2i) can be selected for treatment:

Dapagliflozin 10 mg once daily (QD) or Empagliflozin 10 mg once daily (QD) If the patient has concurrent diabetes, the use of other antidiabetic drugs is not restricted.

The treatment should last for at least 14 days.

Intervention Type: DRUG

Standard medical treatment

According to the guideline-recommended standard treatment, if the patient has diabetes, there is no restriction on the use of other antidiabetic drugs (except SGLT-2 inhibitors).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Patients with acute ischemic stroke (AIS) within ≤ 3 days of onset, with no restrictions on reperfusion therapy
• NIHSS score of 4-25 at the time of randomization
• Pre-stroke mRS score ≤ 1
• Signed informed consent form

Exclusion Criteria

• Presence of intracranial hemorrhage at the time of randomization
• BMI ≤ 18 kg/m²
• Severe renal insufficiency (eGFR < 30 mL/min) or severe liver impairment (Child-Pugh Class C liver function)
• Type 1 diabetes mellitus
• Blood glucose level < 2.7 mmol/L or > 22.2 mmol/L at the time of randomization
• Systolic blood pressure < 95 mmHg at the time of randomization
• History of heart failure
• Use of SGLT-2 inhibitors within 4 weeks prior to randomization
• Intolerance to SGLT-2 inhibitors
• Life expectancy < 3 months
• Pregnant or lactating women
• Already enrolled in another clinical trial
• Other conditions deemed inappropriate for inclusion by the investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Min Lou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Min Lou

Role: CONTACT

lm99@zju.edu.cn

+8615925622176

Other Identifiers

SNPS

Identifier Type: -

Identifier Source: org_study_id