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GLP-1 on Non-ST-Segment Elevation Myocardial Infarction

Plain-language guide to NCT02577848: not phased randomized trial of Liraglutide, 90 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02577848
Phase
not phased
Status
status unknown
Start
2015-10
Completion (planned or actual)
2016-10
Participants
90 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Myocardial Infarction
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Liraglutide.

The investigators planned to evaluate the effects of liraglutide on left ventricular function in patients with non-ST-segment elevation myocardial infarction (NSTEMI).

It had two arms (groups): GLP-1 group (experimental) and placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Patients with non-ST-segment elevation myocardial infarction (NSTEMI) are a heterogeneous group with respect to the risk of having a major adverse cardiac event (MACE).

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose.

GLP-1 may have antioxidant and anti-inflammatory properties, and protect endothelial function.

However, the effects of GLP-1 on NSTEMI patients remain unclear.

Who Took Part

90 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

The full record lists 0 inclusion and 11 exclusion criteria; among the exclusions: unconscious at presentation; had st-segment elevation acute myocardial infarction; NSTEMI requiring emergency percutaneous coronary angiography.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

The Liraglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2015-10 with completion listed for 2016-10.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: left ventricular ejection fractions (time frame: at 3 months).

It also tracked 2 secondary outcomes, for example 6-minute walk distance and treatment-emergent adverse events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 90 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

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.