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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.