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EXAMI

UnknownPhase 3

Effect of Additional Treatment With EXenatide in Patients With an Acute Myocardial Infarction (the EXAMI Trial)

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

40

estimated

Study population

Cardiovascular disease

Key I/E criterion

Primary endpoint

Safety of GLP-1 receptor agonist Exenatide infusion

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01254123
Org study IDNL28593.029.09

Timeline

Milestones

Study first posted2010-12-06estimated
Last update posted2010-12-06estimated
Study start2009-11 (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

>18 and < 80 years of age
First myocardial infarction
ST elevation of more than one mm in at least 2 separate leads on the electrocardiogram (ECG)
Delay between onset of sustained chestpain and PCI < 6 hours.

Exclusion criteria

Cardiac rhythm is other than normal sinus rhythm.
Patient in Killip class 3 or 4 of heart failure
Cardiogenic shock defined as sustained systolic blood pressure ≤ 80mmHg despite fluid hydration.
Post cardiac resuscitation
Need for intra aortic balloon counterpulsation therapy
The patient is unable to hold his/her breath for up to 20 seconds due to age or concomitant illness
No former PCI performed
No recanalisation achieved of the occluded coronary artery
Culprit not in segment 1,2,3,6,7,11,12,13 of the coronary artery
No definite culprit
More than one occluded vessel, or a more than 70% stenosis by visual assessment in a non-culprit vessel.
TIMI 3 flow in culprit lesion at presentation
Decreased renal function eGFR < 30ml/min
Any contraindication for MRI ie: implanted electronic devices such as pacemakers, internal defibrillators, neurostimulators, implanted drug infusion devices, cochlear implants, cerebrovascular clips, claustrophobia. previous vascular surgery: aneurysm clip, carotid artery vascular clamp, aortic clips, venous umbrella spinal/intra-ventricular shunts
Metal fragments in eye, head, ear, skin or shoulder.
Swann-Ganz catheter.
Known pre-existing left ventricular dysfunction measured by any technique (ejection fraction < 45% prior to current admission for myocardial infarction)
Prior myocardial infarction
Prior coronary artery bypass grafting
Moderate to severe cardiac valve disease
Stroke or transient ischemic attack within the previous 24 hours
Serious known concomitant disease with a life expectancy of less than one year
Follow up impossible
Previous participation in a trial within the previous 30 days
Known type I Diabetes Mellitus
Known type II Diabetes Mellitus
Pregnancy and/or lactation

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
5
Cardiovascular outcomes
2
Safety / tolerability / PK
2
Glycemic / diabetes
1

Cardiovascular outcomes

2 endpoints
Secondary/protocol endpoint

Angiographic parameters as Trombolysis In Myocardial Infarction (TIMI) frame count and TIMI blush grade after PCI.

descriptive

Secondary/protocol endpoint

The occurrence within 4 months of a Major Adverse Cardiac Event (MACE) defined as cardiac death, myocardial infarction, coronary bypass grafting, or a repeat PCI .

Expanded / custom MACE composite

composite event, event

componentsCardiovascular death, Myocardial infarction (any), Coronary revascularization

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Serum-glucose levels during the first 72 hours.

descriptive

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint/low confidence

Safety of GLP-1 receptor agonist Exenatide infusion compared to placebo in patients with an acute myocardial infarction undergoing primary PCI

descriptive

Secondary/protocol endpoint

Side effects of exenatide

Treatment-emergent AEs (any)

descriptive

Other (unclassified)

5 endpoints
Secondary/protocol endpoint/low confidence

Infarct size, assessed by means of the final infarct size at 4 months post myocardial infarction (CMRI) as a percentage of the area at risk at 1 week post myocardial infarction (T2 weighed CMRI).

ratio, improvement

Secondary/protocol endpoint/low confidence

Regional myocardial function based on a MRI segmental analysis at 1 weeek and at 4 months post myocardial infarction.

descriptive

Secondary/protocol endpoint/low confidence

Global left ventricular ejection fraction (EF), Left Ventricular End Systolic Volume (LVESV), Left Ventricular End Diastolic Volume (LVEDV) at 1 week and at 4 months post myocardial infarction measured by Cardiac MRI.

descriptive

Secondary/protocol endpoint/low confidence

Regional myocardial function assessed by 2D and 3D echocardiography at 1 week and at 4 months post myocardial infarction.

descriptive

Secondary/protocol endpoint/low confidence

Global left ventricular EF, LVESV, LVEDV at 1 week and at 4 months post myocardial infarction measured by 2D and 3D echocardiography.

descriptive

SNOMED 22298006

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.