SLGT2i for Neuroprotection in Patients With Acute Ischemic Stroke

NCT07105917 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SNPS
• Study Type: interventional
• Target: 1,050
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Distribution of mRS scores at 3 months

  3 months

Secondary Outcomes (12)

• Proportion of patients with mRS scores 0-1 at 3 months

  90 days

• Proportion of patients with mRS scores 0-2 at 3 months

  90 days

• Proportion of patients with mRS scores 0-3 at 3 months

  90 days

• NIHSS scores at Day 7 post-onset/at discharge

  7 days

• Change in NIHSS scores from randomization to Day 7 post-onset/at discharge

  7 days

Study Arms (2)

Experimental: SGLT2i with standard therapy

EXPERIMENTAL

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.

Drug: SGLT-2 inhibitors

Standard therapy

SHAM COMPARATOR

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).

Other: Standard medical treatment

Interventions

SGLT-2 inhibitors 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.

Experimental: SGLT2i with standard therapy

Standard medical treatment 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).

Standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Central Study Contacts

Min Lou

CONTACT

+8615925622176; lm99@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-07