Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies (GALLOP)
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ClinicalTrials.gov Identifier: NCT05920889 |
Recruitment Status :
Recruiting
First Posted : June 27, 2023
Last Update Posted : June 27, 2023
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Condition or disease | Intervention/treatment | Phase |
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Stroke Stroke, Acute Stroke, Ischemic Brain Diseases | Drug: Semaglutide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 140 patients will be randomized to "treatment arm" with semaglutide and standard medical therapy, and "control arm" with standard medical therapy alone in a 1:1 ratio. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies - a Pilot Study |
Actual Study Start Date : | April 23, 2023 |
Estimated Primary Completion Date : | March 31, 2026 |
Estimated Study Completion Date : | December 31, 2026 |
Arm | Intervention/treatment |
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Active Comparator: Semaglutide Group
Prescribe study drug: Patients randomized into the semaglutide group will receive 0.5mg subcutaneous injection of the drug before or during EVT, and 7 days after the procedure. i.e. semaglutide group will receive a total of 2 injections.
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Drug: Semaglutide
0.5mg subcutaneous injection of the drug before or during EVT, and 7 days after the procedure. i.e. patient will receive a total of 2 injections. |
No Intervention: Standard of care
Standard medical therapy
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- Change of Modified Rankin Score [ Time Frame: Day 90 ]Change of Modified Rankin Score to measure degree of disability/dependence. Scores 0-3 is considered good outcome, while scores 4-6 is considered poor outcome.
- Malignant brain edema (MBE) [ Time Frame: From Day 0 post treatment, up to 90 Days. ]Parenchymal hypodensity of at least 50% of the MCA territory and signs of local brain swelling such as sulcal effacement and compression of the lateral ventricle, and Midline shift of ≥5 mm at the septum pellucidum or pineal gland with obliteration of the basal cisterns.
- Symptomatic intracranial hemorrhage (sICH) [ Time Frame: From Day 0 post treatment, up to 90 Days. ]Any parenchymal hemorrhage or hemorrhagic transformation temporally related to any worsening in neurological condition.
- Blood-brain-barrier (BBB) permeability [ Time Frame: From Day 0 post treatment, up to 90 Days. ]Blood-brain-barrier permeability by CT perfusion scan
- Hemorrhagic transformation and parenchymal hemorrhage [ Time Frame: From Day 0 post treatment, up to 90 Days. ]Hemorrhagic transformation and parenchymal hemorrhage as per Heidelberg Bleeding Classification,
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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- LVO stroke at terminal ICA or proximal M1 eligible for emergency endovascular treatment as per current treatment guideline.
- LKW-to-puncture time ≤ 12 hours.
- Age 18 years or greater.
- National Institute of Health Stroke Scale (NIHSS) ≥10
- LVO stroke due to thromboembolism or intracranial stenosis (acute or acute on chronic occlusion).
- Patients who received computer tomographic angiography and perfusion (CTA+P).
- Pre-stroke (24 hours prior to stroke onset) independent functional status with modified Rankin Scale (mRS) ≤ 2.
- Consent process completed as per national laws and regulation and the applicable ethics committee requirements.
Exclusion Criteria:
- ASPECT score ≤ 5.
- Intracranial hemorrhage on pre-EVT imaging.
- LVO etiologies other than thromboembolism or intracranial stenosis (acute or acute on chronic total occlusion), e.g. arterial dissection, infective endocarditis on initial diagnostic imaging.Estimated or known body mass index < 18 kg/m2
- Estimated or known body mass index < 18 kg/m2.
- Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.
- Creatinine clearance < 30mL/min.
- Severe or fatal comorbid illness, e.g. terminal malignancy.
- Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion.
- History of allergy to GLP-1RA.
- Family or personal history of multiple endocrine neoplasia, medullary thyroid carcinoma, pancreatic carcinoma, known proliferative diabetic retinopathy.
- Active sepsis on randomization.
- Patients with hypoglycaemia on presentation. Defined as capillary or serum glucose level of <4mmol/L.
- Patients prone to severe hypoglycaemia, including chronic kidney disease of estimated glomerular filtration rate of 50ml/min/1.73m^2; also those with chronic liver disease with Child's Pugh score C or above; patients with recurrent unexplained hypoglycemia.
- Patient already on GLP-1RA prior to screening.
- Contraindications to iodine-based CT contrast.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05920889
Contact: Bonaventure Yiu Ming IP, MB ChB | 852-28902002 | bonaventureip@cuhk.edu.hk | |
Contact: Thomas Wai Hong LEUNG, MB ChB | 852-28902002 | drtleung@cuhk.edu.hk |
China, Shangdong | |
Linyi People's Hospital | Not yet recruiting |
Linyi, Shangdong, China, 276000 | |
Contact: Fengyuan CHE, MD,PhD fyche1971@163.com | |
Hong Kong | |
Chinese University of Hong Kong | Recruiting |
Hong Kong, Hong Kong | |
Contact: Bonaventure Yiu Ming IP, MB ChB 852-28902002 bonaventureip@cuhk.edu.hk | |
Contact: Thomas Wai Hong LEUNG, MB ChB 852-28902002 drtleung@cuhk.edu.hk |
Principal Investigator: | Bonaventure Yiu Ming IP, MB ChB | Chinese University of Hong Kong | |
Principal Investigator: | Fengyuan CHE, MD,PhD | Linyi People's Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences |
Responsible Party: | Dr. IP Yiu Ming Bonaventure, Assistant Professor, Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT05920889 |
Other Study ID Numbers: |
CREC 2023.026-T |
First Posted: | June 27, 2023 Key Record Dates |
Last Update Posted: | June 27, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Stroke Brain Diseases Ischemic Stroke Cerebrovascular Disorders Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Semaglutide Glucagon-Like Peptide-1 Receptor Agonists Hypoglycemic Agents Physiological Effects of Drugs |