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Trial · Interventional

RecruitingPhase 4Registry data

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

Short name GLUMINS

NCTNCT06324461 (opens ClinicalTrials.gov in a new tab)Other idGLUMINS
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
372 participants (estimated)
Sponsor
The University of Hong Kong · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
20 Mar 2024
Primary completion
31 Dec 2028 (estimated)
Completion
31 Dec 2028 (estimated)
First posted
22 Mar 2024
Last update posted
4 May 2026
Conditions
Myocardial Injury

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026202720282029
  1. Ph 4

    GLUMINS

    NCT06324461

    20 Mar 2024 to est. 31 Dec 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Dulaglutide 0.75mg subcutaneous injectionDrug

Arms2

  • Experimental

    Dulaglutide group

    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

  • No intervention

    Control group

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proportion of patients with MINS

    Time frame · Within 72 hours after surgery

    Registry description

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

Secondary outcomes(11)

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

    Time frame · Within 30 days of randomization

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

    Time frame · Within 30 days of randomization

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

    Time frame · Within 30 days of randomization

  4. Proportion of patients with ischemic stroke

    Time frame · Within 30 days of randomization

  5. Proportion of patients with cardiovascular death

    Time frame · Within 30 days of randomization

  6. Proportion of patients with all-cause mortality

    Time frame · Within 30 days of randomization

  7. Mean days alive and out of hospital

    Time frame · Within 30 days of randomization

  8. Clinically important atrial fibrillation

    Time frame · Within 30 days of randomization

  9. Clinically significant hypoglycaemia

    Time frame · Within 30 days of randomization

  10. Mean peak troponin T concentration

    Time frame · During the period of index hospitalization up to 3 days

  11. Mean area under curve of troponin T concentration

    Time frame · During the period of index hospitalization up to 3 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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