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

ConditionsAcute Ischemic StrokeLarge Vessel OcclusionNeuroprotective DrugsEndovascular Treatment
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWei Hu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide 0.5 mg

    Drug

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

  • Standard medical treatment

    Other intervention

    Standard medical management

Treatment groups

390 Participants
are divided into 2 treatment groups
Group A: semaglutideExperimental treatment 2 interventions
Group B: Standard medical managementPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
90±14 days after procedure

Secondary outcomes

1

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

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)

Time frame
90±14 days after procedure
2

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

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)

Time frame
90±14 days after procedure
3

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

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)

Time frame
90±14 days after procedure
4

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

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

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

Other outcomes

1

Intracranial Hemorrhage (ICH)

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

Time frame
48-72 hours after EVT

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wei Hu

Lead sponsor

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

Sponsor institution

Chinese University of Hong Kong

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: