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NCT Number: NCT06788626

Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke After Endovascular Treatment

The goal of this clinical trial is to learn if semaglutide works to treat acute ischemic stroke (AIS). It will also learn about the safety of semaglutide in AIS. The main question it aims to answer is: Does semaglutide improve the 90-days functional outcome in participants with acute large vessel occlusion who receive the endovascular treatment (EVT)? Researchers will compare semaglutide injection to non-injection to see if semaglutide works to improve the functional outcome in participants with EVT.

Participants will:

* Receive 0.5mg semaglutide injection before (Day 0) and 1 week (Day 7) after EVT , or EVT alone. * Have additional blood test before and after EVT. * Receive neurological assessment before EVT, Day 1, Day 3, Day 5-7 after EVT or on hospital discharge (whichever earlier), Day 90±14 after EVT. Audio or video of the assessment may be recorded if possible. * Receive brain CT + CT angiogram + CT perfusion and MRI after EVT, where the CT scan may be repetitive.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Endovascular Treatment Ischemic Stroke Large Vessel Occlusion Nervous System Diseases Neuroprotective Drugs Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Location contact

Wei Hu, MD,PhD

CONTACT

[email protected]

+8615155510611

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LVO stroke at terminal ICA, M1 or dominant M2 with an LKW-to-randomization ≤24 hours
  • Age ≥ 18 years old
  • National Institute of Health Stroke Scale ≥ 6 at the time of brain imaging
  • Acute LVO stroke due to thromboembolism or intracranial stenosis
  • Patients who received computer tomographic or magnetic resonance angiography
  • ASPECTS ≥ 6 for patients with LKW-to-randomization ≤6 hours
  • Salvageable ischemic penumbra demonstrated by CT perfusion or MRI for patients with LKW-to-randomization between 6 and 24 hours
  • Informed consent obtained from patient or acceptable patient surrogate.

Exclusion criteria

  • Use of intravenous thrombolytic therapy (alteplase or tenecteplase)
  • Pre-stroke mRS > 2 for patients <80 years and > 1 for patients ≥ 80 years old
  • Intracranial hemorrhage or brain tumour on initial imaging (except small meningiomas)
  • Simultaneous occlusion of bilateral anterior circulation, or both anterior and posterior circulation
  • Unstable hemodynamics on presentation that require resuscitation
  • Systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg that cannot be controlled by antihypertensive drugs
  • Severe comorbid illness, e.g. terminal malignancy with life expectancy <1 year
  • Pregnant or lactating female
  • Participation in another clinical trial
  • Contraindications to GLP1-RA, including history of allergy to GLP-1RA, family or personal history of multiple endocrine neoplasia, medullary thyroid or pancreatic carcinoma, or proliferative diabetic retinopathy
  • Blood glucose <2.7 or > 22.2 mmol/L; platelet count <50x10^9 /L; INR >1.7
  • Patients with known estimated glomerular filtration rate of <30ml/min/1.73m2 or creatinine >3mg/dL (265.2µmol/L); chronic liver disease with Child's Pugh score C or above; or recurrent unexplained hypoglycemia.
  • Suspected or confirmed vasculitis of the central nervous system
  • Unable to complete 90-day follow-up assessment

Treatment and study plan

Semaglutide 0.5 mg

Drug

0.5mg semaglutide injection before and 1 week after endovascular treatment.

Standard Medical Treatment

Other

Standard medical management

Primary outcomes

  1. The ordinal shift of modified Rankin Scale

    Time frame: 90±14 days after procedure

    The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death

Secondary outcomes

  1. Proportion of patients with functional independence outcome (mRS 0-1) at day 90

    Time frame: 90±14 days after procedure

    Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

  2. Proportion of patients with functional independence outcome (mRS 0-2) at day 90

    Time frame: 90±14 days after procedure

    modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

  3. Proportion of patients with ambulatory and self-care capable outcome (mRS 0-3) at day 90

    Time frame: 90±14 days after procedure

    Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

  4. Neurological Function of Participants Assessed by National Institute of Health Stroke Scale

    Time frame: Day 1, Day 3, Day 5-7 after EVT (or at discharge, when the patient is discharged on day 5-7)

    Zero indicates no stroke symptoms, 1-4 , 5-15, 16-20, 21-42 indicate minor, moderate, moderate to severe, and severe stroke, respectively.

  5. Health-related Quality of Life of Participants Assessed by EuroQol-5 Dimension-5 Level

    Time frame: 90±14 days after endovascular treatment

    Participants rated themselves on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension was distributed from "no problems at all" to "very serious problems".

  6. Activities of Daily Living of Participants Assessed by Bathel Index

    Time frame: 90±14 days after procedure

    10 rating items, each of which is categorized into 2-3 out of 5 levels: Unable, Needs major help, Needs help, Needs minor help, and Independent, and each item has a different score for each level. Independence was positively correlated with the final score.

Other outcomes

  1. Intracranial Hemorrhage (ICH)

    Time frame: 48-72 hours after EVT

    ICH means Heidelberg classification 2 or above intracerebral hemorrhage with increment of NIHSS ≥ 4.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Hu, MD, PhD

CONTACT

[email protected]

+86 055162284313

Sponsors and collaborators

Lead sponsor

Wei Hu

Other

Collaborators

  • Chinese University of Hong Kong

Registry information

Acronym: GALLOP2

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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