Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial

Conditions

• Acute Ischemic Stroke (AIS)

Eligibility Criteria

Sex

ALL

Age

19 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Tirzepatide — DRUG
  Participants will receive two subcutaneous injections of tirzepatide (5 mg each): the first administered before EVT and the second administered 7 days after EVT, in addition to standard medical care
• Standard Medical Care (SMC) — OTHER
  Participants will receive EVT and standard medical care without tirzepatide.

Study Details

Acute ischemic stroke caused by blockage of a large artery in the brain is one of the leading causes of death and long-term disability worldwide. For patients with this type of stroke, endovascular thrombectomy (EVT), a procedure that removes the blood clot and restores blood flow to the brain, has become the standard treatment. However, even when blood flow is successfully restored, many patients continue to experience disability because of ongoing brain injury caused by inflammation, oxidative stress, and damage to brain cells after the stroke. This study aims to evaluate whether tirzepatide, a medication that activates both glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) pathways, can improve recovery in patients with acute ischemic stroke caused by large vessel occlusion who receive thrombectomy. Tirzepatide is currently approved for the treatment of conditions such as type 2 diabetes and obesity. Previous studies have shown that tirzepatide can improve blood sugar control, reduce body weight, and provide beneficial effects on cardiovascular health. Laboratory studies and early clinical evidence suggest that medications targeting GLP-1 and GIP pathways may also have protective effects on the brain by reducing inflammation, protecting brain cells, improving blood vessel function, and supporting recovery after stroke. In this study, eligible patients with acute ischemic stroke caused by blockage of a major brain artery will be randomly assigned to receive either tirzepatide plus standard stroke care or standard stroke care alone. Participants will receive two subcutaneous injections of tirzepatide: the first dose before the thrombectomy procedure and the second dose 7 days after the procedure. The study will include multiple hospitals and will use independent assessment of outcomes to ensure reliable evaluation of treatment effects. The primary purpose of this study is to determine whether early treatment with tirzepatide can improve functional recovery 90 days after stroke, measured by the patient's ability to perform daily activities and live independently. The study will also evaluate whether tirzepatide is safe in patients with acute ischemic stroke by monitoring adverse events, complications, and other clinical outcomes. The findings from this study may provide important evidence for a new treatment approach to improve recovery after thrombectomy and reduce disability among patients with severe ischemic stroke.

Key Dates

First listed

Jul 29, 2026

Start date

Aug 10, 2026

Status verified

Jul 2026

Primary completion

May 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

430 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tirzepatide Intervention Group
  Participants will receive two subcutaneous injections of tirzepatide: the first administered before EVT and the second administered 7 days after EVT, in addition to standard medical care
• Active Comparator: Control Group
  Participants will receive EVT and standard medical care without tirzepatide.

Primary Outcome Measure

The primary efficacy outcome: Proportion of patients achieving an excellent functional outcome [ Time Frame: 90 ± 7 days after randomization ]

Central Contacts

• Guodong Xiao, MD.PhD
  +8618020289268
  [email protected]
• Shoujiang You, MD.PhD
  +8615995738506
  [email protected]