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

ConditionMyocardial Injury

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of symptomatic hypoglycemia within 1 month of recruitment

History of pancreatitis

Diabetic retinopathy

Personal or family history of medullary thyroid carcinoma (MTC)

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

372 Participants

are divided into 2 treatment groups

Group A: Dulaglutide groupExperimental treatment 1 intervention

Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Proportion of patients with MINS

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

Time frame

Within 72 hours after surgery

Secondary outcomes

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

Time frame