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Efficacy Study of Glucagonlike Peptide-1 to Treat Reperfusion Injury

Plain-language guide to NCT02001363: not phased randomized trial of Liraglutide, 90 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02001363
Phase
not phased
Status
status unknown
Start
2013-11
Completion (planned or actual)
2016-03
Participants
90 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Acute 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 research the cardioprotective effects of intravenous liraglutide on reperfusion injury.

It had two arms (groups): liraglutide (experimental) and liraglutide placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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

However, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and recently GLP-1 analogues have been introduced for the treatment of type-2 diabetes.

The investigators planned to research the cardioprotective effects of intravenous liraglutide administered prior to reperfusion and continued after restoration of coronary blood flow in patients with STEMI undergoing pPCI.

Who Took Part

The registry lists 90 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.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant and care provider.

It started in 2013-11 with completion listed for 2016-03.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): the salvage index measured by cardiac magnetic resonance (time frame: 3 months after primary percutaneous coronary intervention).

It also tracked 4 secondary outcomes, for example major adverse cardiovascular events (MACE) after 3 months, final infarct size after 3 months, the levels of high-sensitivity C-reactive protein (hsCRP) and nitric oxide (NO) levels.

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.