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

NCT06788626 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: GALLOP2
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke; Large Vessel Occlusion; Neuroprotective Drugs; Endovascular Treatment

Outcome Measures

Primary Outcomes (1)

• The ordinal shift of modified Rankin Scale

  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

  90±14 days after procedure

Secondary Outcomes (6)

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

  90±14 days after procedure

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

  90±14 days after procedure

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

  90±14 days after procedure

• Neurological Function of Participants Assessed by National Institute of Health Stroke Scale

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

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

  90±14 days after endovascular treatment

Other Outcomes (1)

• Intracranial Hemorrhage (ICH)

  48-72 hours after EVT

Study Arms (2)

semaglutide

EXPERIMENTAL

Participants will receive 0.5mg semaglutide injection before (Day 0) and 1 week (Day 7) after EVT. Additionally, they will receive antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.

Drug: Semaglutide 0.5 mg; Other: Standard medical treatment

Standard medical management

PLACEBO COMPARATOR

Standard medical management. Participants will receive EVT, antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.

Other: Standard medical treatment

Interventions

Semaglutide 0.5 mg DRUG

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

semaglutide

Standard medical treatment OTHER

Standard medical management

Standard medical management; semaglutide

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wei Hu: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

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

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

semaglutide

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wei Hu, MD, PhD

CONTACT

+86 055162284313; andinghu@ustc.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: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 23, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)