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Trial · Interventional

Status unknownNot applicableRegistry data

Efficacy Study of Glucagonlike Peptide-1 to Treat Reperfusion Injury

NCTNCT02001363 (opens ClinicalTrials.gov in a new tab)Other idS2013-099-01Other idChinaPLAGH
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
90 participants (estimated)
Sponsor
Chen Wei Ren, MD · Other
Design
Randomized · Double masking
Countries
1 country

China

Start
Nov 2013
Primary completion
Mar 2016 (estimated)
Completion
Mar 2016 (estimated)
First posted
4 Dec 2013 (estimated)
Last update posted
5 Feb 2016 (estimated)
Conditions
Acute Myocardial Infarction

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. N/A

    Efficacy Study of Glucagonlike Peptide-1 to Treat Reperfusion Injury

    NCT02001363

    Nov 2013 to est. Mar 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The investigators planned to research the cardioprotective effects of intravenous liraglutide on reperfusion injury.

Interventions

  • liraglutide (Novo Nordisk, Bagsværd, Denmark)Drug
  • liraglutide placebo (Novo Nordisk)Drug

Arms2

  • Experimental

    liraglutide

    drug: liraglutide (Novo Nordisk, Bagsværd, Denmark) duration:7 days(from admission (primary percutaneous coronary intervention) to discharge) the intervention:once-daily subcutaneous liraglutide 0.6 mg for 2 days, then gradually increase the dosage, once-daily subcutaneous liraglutide 1.2 mg for 2 days ,once-daily subcutaneous liraglutide 1.8 mg for 3 days

  • Placebo comparator

    liraglutide placebo

    drug:liraglutide placebo (Novo Nordisk) duration:7 days(from admission (primary percutaneous coronary intervention) to discharge) the intervention:once-daily subcutaneous liraglutide placebo 0.6 mg for 2 days, then gradually increase the dosage, once-daily subcutaneous liraglutide placebo 1.2 mg for 2 days ,once-daily subcutaneous liraglutide placebo 1.8 mg for 3 days

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. the salvage index measured by cardiac magnetic resonance

    Time frame · 3 months after primary percutaneous coronary intervention

    Registry description

    The primary endpoint was the salvage index measured by cardiac magnetic resonance after 3 months.

Secondary outcomes(4)

  1. major adverse cardiovascular events (MACE) after 3 months

    Time frame · 3 months after Primary percutaneous coronary intervention

    Registry description

    major adverse cardiovascular events (MACE) after 3 months: recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death. treatment-emergent adverse events (TEAEs): hypoglycemia, nausea, acute pancreatitis

  2. final infarct size after 3 months

    Time frame · 3 months after Primary percutaneous coronary intervention

  3. the levels of high-sensitivity C-reactive protein (hsCRP)

    Time frame · 3 months after Primary percutaneous coronary intervention

  4. nitric oxide (NO) levels

    Time frame · 3 months after Primary percutaneous coronary intervention

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2016

5 results

Effects of Liraglutide on Reperfusion Injury in Patients With ST-Segment-Elevation Myocardial Infarction.

Chen et al. 2016Circulation. Cardiovascular imagingcited by 84

PMID 27940956DOI 10.1161/circimaging.116.005146PUB-27940956

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Randomized controlled trial · 2012

8 results

Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction.

Lønborg et al. 2012European heart journalcited by 421

PMID 21920963DOI 10.1093/eurheartj/ehr309PUB-21920963

Rights unknown8 results
Source linkSee results (8)

Indexing hint: Randomized controlled trial · 2009

4 results

Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial.

Garber et al. 2009Lancet (London, England)cited by 798

PMID 18819705DOI 10.1016/s0140-6736(08)61246-5PUB-18819705

Full text at the publisher4 results
Publisher pageSee results (4)

More studies

2 studies on this page

Indexing hint: In vitro study · 2009

A long-acting glucagon-like peptide-1 analogue attenuates induction of plasminogen activator inhibitor type-1 and vascular adhesion molecules.

Liu et al. 2009The Journal of endocrinologycited by 155

PMID 19136619DOI 10.1677/joe-08-0468PUB-19136619

Rights unknown
Source link

PubMed tag: none · 2009

GLP-1R agonist liraglutide activates cytoprotective pathways and improves outcomes after experimental myocardial infarction in mice.

Noyan-Ashraf et al. 2009Diabetescited by 463

PMID 19151200PMC2661586DOI 10.2337/db08-1193PUB-19151200

Free to read · publisher termsCC BY-NC-ND
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHuang M, Wei R, Wang Y, Su T, Li Q, Yang X, Chen X. Protective effect of glucagon-like peptide-1 agents on reperfusion injury for acute myocardial infarction: a meta-analysis of randomized controlled trials. Ann Med. 2017 Nov;49(7):552-561. doi: 10.1080/07853890.2017.1306653. Epub 2017 Mar 31. PMID 28286967

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Patients were eligible if they were 18 years or older and presented within 12 h from the onset of symptoms and signs of ST-segment elevation myocardial infarction to the catheterization laboratory. Exclusion Criteria: The patients were not considered for enrolment if they presented with unconsciousness, cardiogenic shock, hypoglycaemia, diabetic ketoacidosis, previous myocardial infarction, stent thrombosis, known renal insufficiency, or previous coronary artery bypass operation.

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