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NCT07105917Not yet recruitingPhase 3

SLGT2i for Neuroprotection in Patients With Acute Ischemic Stroke

Sodium-dependent Glucose Transporters 2 Inhibitor for Neuroprotection in Patients With Acute Ischemic Stroke

Source: ClinicalTrials.gov · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1050 (estimated)
First submitted
30 Jul 2025
Start date
1 Aug 2025
Primary completion date
1 Aug 2026
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Diseases
Stroke
NCT number
NCT07105917

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1050
  • From 1 Aug 2025 to the primary completion date, 1 Aug 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of SGLT-2 inhibitors within 4 weeks prior to randomization
  • Intolerance to SGLT-2 inhibitors

Other illness

  • Presence of intracranial hemorrhage at the time of randomization
  • Type 1 diabetes mellitus
  • History of heart failure
  • Other conditions deemed inappropriate for inclusion by the investigator

Lab values

  • Severe renal insufficiency (eGFR \< 30 mL/min) or severe liver impairment (Child-Pugh Class C liver function)
  • Blood glucose level \< 2.7 mmol/L or \> 22.2 mmol/L at the time of randomization

Other

  • BMI ≤ 18 kg/m²
  • Systolic blood pressure \< 95 mmHg at the time of randomization
  • Life expectancy \< 3 months
  • Pregnant or lactating women
  • Already enrolled in another clinical trial

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.