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

NCT06324461 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: GLUMINS
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Myocardial Injury

Keywords

Myocardial injury following non-cardiac surgery; glucagon-like peptide 1 receptor agonists; Dulaglutide

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with MINS

  Defined as any elevation in troponin T \>= 14ng/L

  Within 72 hours after surgery

Secondary Outcomes (11)

• Proportion of patients with composite of non-fatal MINS, non-fatal stroke or cardiovascular mortality

  Within 30 days of randomization

• Proportion of patients with MINS who do not fulfill the 4th universal definition of myocardial infarction

  Within 30 days of randomization

• Proportion of patients with myocardial infarction according to the 4th universal definition of myocardial infarction

  Within 30 days of randomization

• Proportion of patients with ischemic stroke

  Within 30 days of randomization

• Proportion of patients with cardiovascular death

  Within 30 days of randomization

Other Outcomes (14)

• Proportion of patients with coronary revascularization

  Within 30 days of randomization

• Proportion of patients who require readmission for cardiovascular conditions

  Within 30 days of randomization

• Proportion of patients with non-fatal cardiac arrest

  Within 30 days of randomization

Study Arms (2)

Dulaglutide group

EXPERIMENTAL

Subject randomized into this group will receive single subcutaneous dose of Dulaglutide 0.75mg 1 to 14 days prior to surgery, on top of routine peri-operative care

Drug: Dulaglutide 0.75mg subcutaneous injection

Control group

NO INTERVENTION

Subject randomized into this group will receive routine peri-operative care

Interventions

Dulaglutide 0.75mg subcutaneous injection DRUG

Subject randomized into treatment group will receive single subcutaneous dose of Dulaglutide 0.75mg 1 to 14 days prior to surgery

Also known as: Trulicity 0.75mg subcutaneous injection

Dulaglutide group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Research Grants Council, Hong Kong: collaborator
• The University of Hong Kong: lead

Study Sites (3)

Duchess of Kent Children's Hospital at Sandy Bay

Hong Kong, Hong Kong SAR, China

NOT YET RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong SAR, China

RECRUITING

Tung Wah Hospital

Hong Kong, Hong Kong SAR, China

RECRUITING

Related Publications (2)

• Writing Committee for the VSI, Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS and Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017;317:1642-1651.

  BACKGROUND

• 1. Halvorsen S, Mehilli J, Cassese S, Hall TS, Abdelhamid M, Barbato E, De Hert S, de Laval I, Geisler T, Hinterbuchner L, Ibanez B, Lenarczyk R, Mansmann UR, McGreavy P, Mueller C, Muneretto C, Niessner A, Potpara TS, Ristic A, Sade LE, Schirmer H, Schupke S, Sillesen H, Skulstad H, Torracca L, Tutarel O, Van Der Meer P, Wojakowski W, Zacharowski K, Group ESCSD, Knuuti J, Kristensen SD, Aboyans V, Ahrens I, Antoniou S, Asteggiano R, Atar D, Baumbach A, Baumgartner H, Bohm M, Borger MA, Bueno H, Celutkiene J, Chieffo A, Cikes M, Darius H, Delgado V, Devereaux PJ, Duncker D, Falk V, Fauchier L, Habib G, Hasdai D, Huber K, Iung B, Jaarsma T, Konradi A, Koskinas KC, Kotecha D, Landmesser U, Lewis BS, Linhart A, Lochen ML, Maeng M, Manzo-Silberman S, Mindham R, Neubeck L, Nielsen JC, Petersen SE, Prescott E, Rakisheva A, Saraste A, Sibbing D, Siller-Matula J, Sitges M, Stankovic I, Storey RF, Ten Berg J, Thielmann M and Touyz RM. 2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Eur Heart J. 2022.

  BACKGROUND

MeSH Terms

Interventions

dulaglutide; Injections, Subcutaneous

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Chun Ka Wong, Clinical Assistant Professor

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Ka Wong, Clinical Assistant Professor

CONTACT

+852 2255 3597; wongeck@hku.hk

Lily Hung, Master

CONTACT

+852 2255 4169; nga98@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Open-labelled, superiority randomized controlled trial

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: March 22, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CN (3)