RecruitingPhase 4

GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery

China372 participantsStarted 2024-03-20

Plain-language summary

This is an investigator initiated, multi-center, open-labelled, superiority randomized controlled trial of 372 patients undergoing elective non-cardiac surgery. Recruited patients will be randomized in a 2:1 ratio to receive single subcutaneous dose of Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RAs) 1 to 14 days prior to surgery or receive routine care. Dulaglutide (Trulicity; Eli Lilly, USA) is chosen as GLP-1 Receptor Agonists investigational drug for this study. Apart from peri-operative routine care, all recruited subjects will undergo physical, respiratory and cardiac assessments including electrocardiography and blood check including cardiac enzymes. Myocardial injury, cardiovascular outcomes and safety will be assessed and evaluated for efficacy and safety of this prophylactic measurement for the reduction of myocardial injury after non-cardiac surgery.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years * Planned elective intermediate to high risk non-cardiac surgery * Anticipated to remain hospitalized for at least one night after surgery * Voluntarily agrees to participate by providing written informed consent Exclusion Criteria: * History of symptomatic hypoglycemia within 1 month of recruitment * History of pancreatitis * Diabetic retinopathy * Personal or family history of medullary thyroid carcinoma (MTC) * Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) * Acute coronary syndrome, decompensated heart failure, cardiogenic shock, or myocarditis within 1 month of recruitment * Stroke or transient ischemic attack within 1 month of recruitment * Known severe liver disease (Child-Pugh B or C) * Stage 5 chronic kidney disease (estimated glomerular filtration rate (eGFR) by Modified Diet in Renal Disease (MDRD) equation \< 15 mL/min) * Recent use of GLP-1 RA within 1 month of recruitment * Known allergy or hypersensitivity to GLP-1 RA * Women of childbearing age who are not taking effective contraception, or who are pregnant or breast-feeding * Use of Dipeptidyl peptidase-4 inhibitor(DPP4i)

What they're measuring

Proportion of patients with MINS

Timeframe: Within 72 hours after surgery

Trial details

NCT IDNCT06324461

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Chun Ka Wong, Clinical Assistant Professor

+852 2255 3597 wongeck@hku.hk