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

Plain-language guide to NCT06324461: phase 4 randomized trial of Dulaglutide, 372 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06324461
Phase
phase 4
Status
recruiting participants
Start
2024-03-20
Completion (planned or actual)
2028-12-31
Participants
372 (estimated)
Design
randomized, open label (everyone knows who gets what), prevention
Conditions studied
Myocardial Injury
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Dulaglutide.

It had two arms (groups): Dulaglutide group (experimental) and Control group (no intervention).

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

The registry classes the interventions as drug.

More on the Plan

Post-operative troponin T level strongly correlated with peri-operative mortality.

This study will evaluate the effect of pre-operative glucagon-like peptide 1 receptor agonists (GLP-1 RAs) on MINS.

GLP-1 is a peptide hormone produced by intestinal epithelial endocrine L-cells that stimulates insulin secretion and inhibits glucagon secretion.

GLP-1 RAs have been used to treat both diabetic and non-diabetic conditions.

Who Took Part

372 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: history of symptomatic hypoglycemia within 1 month of recruitment; history of pancreatitis; diabetic retinopathy.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Dulaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Dulaglutide study did not mask who received what.

It started in 2024-03-20 with completion listed for 2028-12-31.

It ran at 3 sites in China (3).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Proportion of patients with MINS (time frame: Within 72 hours after surgery).

It also tracked 11 secondary outcomes, for example Proportion of patients with composite of non-fatal MINS, non-fatal stroke or cardiovascular mortality, Proportion of patients with MINS who do not fulfill the 4th universal definition of myocardial infarction, Proportion of patients with myocardial infarction according to the 4th universal definition of myocardial infarction, Proportion of patients with ischemic stroke, Proportion of patients with all-cause mortality and Mean days alive and out of hospital.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Dulaglutide in 372 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, all human trials.

Our Notes on the Compound

Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.