Acute ST-segment Elevation Myocardial InfarctionNCT02507128
Effects of Glucagon Like Peptide-1 on No-reflow
A study testing liraglutide in people with Acute ST-segment Elevation Myocardial Infarction, run by Chen Wei Ren, MD at 1 site in China.
Trial summary
The investigators planned to evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute ST-segment Elevation Myocardial Infarction
- What is being tested?
- liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ST-segment elevation myocardial infarction were eligible for the study.
Who cannot join
- Patients were excluded for the following reasons: unconscious at presentation; had cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; had a history of myocardial infarction, stent thrombosis, or renal insufficiency; or had previously undergone coronary artery bypass surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PLA General Hospital
Beijing, Beijing Municipality, 100853
Wei Ren Chen, M.D., +8610-66939709, chen_weiren@sina.com
Yun Dai Chen, M.D.
About this study
Official title: Effects of Glucagon Like Peptide-1 on No-reflow in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
The investigators planned to evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI).
Read the detailed description
Acute myocardial infarction (AMI) is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (PCI) is currently the most effective treatment strategy for AMI. Brisk thrombolysis in myocardial infarction (TIMI) grade 3 flow immediately after PCI in patients with AMI is associated with improved clinical outcomes compared with lower flow grades. 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. To date, however, very few drugs have been shown to reverse established no-reflow.
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. GLP-1 has antioxidant and anti-inflammatory properties, and may protect endothelial function. Experimental studies have also revealed that GLP-1 or its analogues protect against reperfusion injury in pigs. Exenatide, a GLP-1 analogue, was reported to reduce reperfusion injury in patients with ST-segment elevation myocardial infarction. Similarly, liraglutide was reported to reduce cardiac rupture and infarct size and improve cardiac output in normal and diabetic mice. To date, however, there is no clinical evidence for the effects of liraglutide on no-reflow in patients with AMI. Therefore, the aim of this study was to evaluate the effects of liraglutide pretreatment on myocardial no-reflow of prime PCI in patients with AMI.
- Being tested
- liraglutide, placebo
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Also called glucagon like peptide-1
Liraglutide were taken 30 min before PCI.
placeboDrug
Placebo were taken 30 min before PCI.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 group | Experimental | The treatment started 30 min before PCI with a dose of 1.8 mg liraglutide (the treatment was administered in the ambulance). Receives: Drug: liraglutide |
| Control group | Placebo comparator | the treatment started 30 min before PCI with a dose of 1.8 mg placebo (the treatment was administered in the ambulance). Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
a change in the prevalence of no-reflow
The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure.
Measured: immediately after PCI
Secondary outcomes (3)
a change in troponin T
Secondary efficacy variable was troponin T level.
Measured: immediately after PCI, at 1,3,5 days after PCI
a change in high-sensitivity C-reactive protein (hsCRP)
Secondary efficacy variable was high-sensitivity C-reactive protein level.
Measured: immediately after PCI, at 1,3,5 days after PCI
a change in superoxide dismutase (SOD)
Secondary efficacy variable was superoxide dismutase level.
Measured: immediately after PCI, at 1,3,5 days after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Wei Ren, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Wei Ren, MD, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507128
- Sponsor's protocol ID
- 301xnk
- Status last verified
- Jul 2015
- First submitted
- 22 Jul 2015
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.
PubMed 12517460Gibson CM, Cannon CP, Murphy SA, Marble SJ, Barron HV, Braunwald E; TIMI Study Group. Relationship of the TIMI myocardial perfusion grades, flow grades, frame count, and percutaneous coronary intervention to long-term outcomes after thrombolytic administration in acute myocardial infarction. Circulation. 2002 Apr 23;105(16):1909-13. doi: 10.1161/01.cir.0000014683.52177.b5.
PubMed 11997276Rezkalla SH, Kloner RA. Coronary no-reflow phenomenon: from the experimental laboratory to the cardiac catheterization laboratory. Catheter Cardiovasc Interv. 2008 Dec 1;72(7):950-7. doi: 10.1002/ccd.21715.
PubMed 19021281Muller O, Trana C, Eeckhout E. Myocardial no-reflow treatment. Curr Vasc Pharmacol. 2013 Mar 1;11(2):278-85.
PubMed 23506504Timmers L, Henriques JP, de Kleijn DP, Devries JH, Kemperman H, Steendijk P, Verlaan CW, Kerver M, Piek JJ, Doevendans PA, Pasterkamp G, Hoefer IE. Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury. J Am Coll Cardiol. 2009 Feb 10;53(6):501-10. doi: 10.1016/j.jacc.2008.10.033.
PubMed 19195607
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Glucagon Like Peptide-1 on No-reflow in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02507128
- Acronym / sponsor ID
- 301xnk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Chen Wei Ren, MDUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators planned to evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI).
Detailed description
Acute myocardial infarction (AMI) is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (PCI) is currently the most effective treatment strategy for AMI. Brisk thrombolysis in myocardial infarction (TIMI) grade 3 flow immediately after PCI in patients with AMI is associated with improved clinical outcomes compared with lower flow grades. 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. To date, however, very few drugs have been shown to reverse established no-reflow.
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. GLP-1 has antioxidant and anti-inflammatory properties, and may protect endothelial function. Experimental studies have also revealed that GLP-1 or its analogues protect against reperfusion injury in pigs. Exenatide, a GLP-1 analogue, was reported to reduce reperfusion injury in patients with ST-segment elevation myocardial infarction. Similarly, liraglutide was reported to reduce cardiac rupture and infarct size and improve cardiac output in normal and diabetic mice. To date, however, there is no clinical evidence for the effects of liraglutide on no-reflow in patients with AMI. Therefore, the aim of this study was to evaluate the effects of liraglutide pretreatment on myocardial no-reflow of prime PCI in patients with AMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 group | Experimental | Drug: liraglutideThe treatment started 30 min before PCI with a dose of 1.8 mg liraglutide (the treatment was administered in the ambulance). |
| Control group | Placebo comparator | Drug: placebothe treatment started 30 min before PCI with a dose of 1.8 mg placebo (the treatment was administered in the ambulance). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ST-segment elevation myocardial infarction were eligible for the study.
Key exclusion criteria (1 listed)
- Patients were excluded for the following reasons: unconscious at presentation; had cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; had a history of myocardial infarction, stent thrombosis, or renal insufficiency; or had previously undergone coronary artery bypass surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutideAlso: glucagon like peptide-1Liraglutide were taken 30 min before PCI. | Drug | GLP-1 group |
| placeboPlacebo were taken 30 min before PCI. | Drug | Control group |
Primary outcome
a change in the prevalence of no-reflow
Time frame: immediately after PCI
The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure.
3 secondary outcomes
a change in troponin T
Time frame: immediately after PCI, at 1,3,5 days after PCI
a change in high-sensitivity C-reactive protein (hsCRP)
Time frame: immediately after PCI, at 1,3,5 days after PCI
a change in superoxide dismutase (SOD)
Time frame: immediately after PCI, at 1,3,5 days after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Background: PubMed 12517460Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.
- Background: PubMed 11997276Gibson CM, Cannon CP, Murphy SA, Marble SJ, Barron HV, Braunwald E; TIMI Study Group. Relationship of the TIMI myocardial perfusion grades, flow grades, frame count, and percutaneous coronary intervention to long-term outcomes after thrombolytic administration in acute myocardial infarction. Circulation. 2002 Apr 23;105(16):1909-13. doi: 10.1161/01.cir.0000014683.52177.b5.
- Background: PubMed 19021281Rezkalla SH, Kloner RA. Coronary no-reflow phenomenon: from the experimental laboratory to the cardiac catheterization laboratory. Catheter Cardiovasc Interv. 2008 Dec 1;72(7):950-7. doi: 10.1002/ccd.21715.
- Background: PubMed 23506504Muller O, Trana C, Eeckhout E. Myocardial no-reflow treatment. Curr Vasc Pharmacol. 2013 Mar 1;11(2):278-85.
- Background: PubMed 19195607Timmers L, Henriques JP, de Kleijn DP, Devries JH, Kemperman H, Steendijk P, Verlaan CW, Kerver M, Piek JJ, Doevendans PA, Pasterkamp G, Hoefer IE. Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury. J Am Coll Cardiol. 2009 Feb 10;53(6):501-10. doi: 10.1016/j.jacc.2008.10.033.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liraglutide in people with Acute ST-segment Elevation Myocardial Infarction, run by Chen Wei Ren, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei ren chen, M.D. (+8601066876221, chen_weiren@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a change in the prevalence of no-reflow (time frame: immediately after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02507128, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.