NCT06788626Not yet recruitingPhase 3
Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke After Endovascular Treatment
Source: ClinicalTrials.gov · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 390 (estimated)
- First submitted
- 14 Jan 2025
- Start date
- Feb 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- Wei Hu
- Diseases
- Stroke
- NCT number
- NCT06788626
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 390
- From Feb 2025 to the primary completion date, Feb 2028
- 1 site in 1 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 intravenous thrombolytic therapy (alteplase or tenecteplase)
- Systolic blood pressure \>185mmHg or diastolic blood pressure \>110mmHg that cannot be controlled by antihypertensive drugs
Other illness
- Intracranial hemorrhage or brain tumour on initial imaging (except small meningiomas)
- Severe comorbid illness, e.g. terminal malignancy with life expectancy \<1 year
- 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
Lab values
- 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.
Age
- Pre-stroke mRS \> 2 for patients \<80 years and \> 1 for patients ≥ 80 years old
Other
- Simultaneous occlusion of bilateral anterior circulation, or both anterior and posterior circulation
- Unstable hemodynamics on presentation that require resuscitation
- Pregnant or lactating female
- Participation in another clinical trial
- Suspected or confirmed vasculitis of the central nervous system
- Unable to complete 90-day follow-up assessment
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.