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Effects of Glucagon Like Peptide-1 on No-reflow

Plain-language guide to NCT02507128: not phased randomized trial of Liraglutide, 190 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02507128
Phase
not phased
Status
status unknown
Start
2015-07
Completion (planned or actual)
2016-07
Participants
190 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Acute ST-segment Elevation Myocardial Infarction
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Liraglutide.

The investigators planned to evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI).

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

The registry classes the interventions as drug.

More on the Plan

Acute myocardial infarction (AMI) is a major cause of mortality and morbidity.

However, myocardial reperfusion is suboptimal in many patients, mostly because of the 'no-reflow' phenomenon.

No-reflow is defined as suboptimal myocardial reperfusion in part of the coronary circulation without angiographic evidence of mechanical vessel obstruction.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction.

Who Took Part

190 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.

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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.

It started in 2015-07 with completion listed for 2016-07.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: a change in the prevalence of no-reflow (time frame: immediately after PCI).

It also tracked 3 secondary outcomes, for example a change in troponin T, a change in high-sensitivity C-reactive protein (hsCRP) and a change in superoxide dismutase (SOD).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 190 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.