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COMBAT-MI

CompletedPhase 3

COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

378

actual

Study population

Cardiovascular disease

Key I/E criterion

—

Primary endpoint

•Myocardial Infarct Size

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 IDNCT02404376

Org study IDCOMBAT-MI

Timeline

Milestones

Study first posted2015-03-31estimated

Last update posted2020-11-03actual

Study start2016-03actual (month precision)

Primary completion2019-08actual (month precision)

Study completion2020-06actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Cardiovascular disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men or women ≥18 years of age

•STEMI characterized by 2 mm ST segment elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV(millivolt) ST segment elevation in the limb leads (II, III and aVF leads, I, aVL leads) and V4-V6.

•Patients presenting within 6 hours of chest pain.

Exclusion criteria

•Known hypersensitivity to exenatide or any of the excipients

•Known contraindication to CMR imaging such as significant claustrophobia, severe allergy to gadolinium chelate contrast, severe renal insufficiency (defined as estimated glomerular filtration rate [eGFR] (epidermal growth factor receptor) <30 mL/min/1.73 m2), presence of CMRI contraindicated implanted devices (e.g., pacemaker, implanted cardiac defibrillator, cardiac resynchronization therapy device, cochlear implant), embedded metal objects (e.g., shrapnel), or any other contraindication for CMRI.

•Assumed life expectancy < 1 year e.g. due to non-cardiac disease.

•TIMI flow grade > 1 at the time of diagnostic coronary angiography. These patients will be excluded from the analysis of infarct size but will be included in the safety analysis.

•Pregnant women

•Patients with loss of consciousness or confused, not able to read the information and to sign the writting consent

•Patients with oro-tracheal intubation

•Patients with cardiogenic shock persisting 48h after reperfusion

Endpoints (9)

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

Cardiovascular outcomes

Other (unclassified)

Cardiovascular outcomes

5 endpoints

Primary/protocol endpoint/low confidence

Myocardial Infarct Size

Time frame:3-7 days after pPCI

descriptive, improvement

Secondary/protocol endpoint/low confidence

Myocardial salvage index

Time frame:3-7 days after pPCI

descriptive

Secondary/protocol endpoint/low confidence

Microvascular obstruction

Time frame:3-7 days after pPCI

descriptive, improvement

Secondary/protocol endpoint

Markers of successful reperfusion

Time frame:First 90 min after reperfusion

descriptive

Secondary/protocol endpoint

Major adverse cardiac events (MACE)

Time frame:Hospital discharge and expected average of 1 week, one year follow-up

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, Myocardial infarction (any), Heart-failure hospitalization

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Transmurality index

Time frame:3-7 days after pPCI

ratio, improvement

Secondary/protocol endpoint/low confidence

Ventricular volumes

Time frame:3-7 days after pPCI

descriptive

Other/protocol endpoint/low confidence

Substudy: Biomarker analysis in Hospital Universitari Vall d'Hebron Biobank (HUVH Biobank)

Time frame:pre- pPCI

descriptive

Other/protocol endpoint

PRESPECIFIED SUBGROUP ANALYSIS ACCORDING TO TOTAL ISCHEMIC TIME

Time frame:3-7 days after pPCI

descriptive

Publications (5)

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.

Registry references + supporting bibliography

Spontaneous reperfusion enhances succinate concentration in peripheral blood from stemi patients but its levels does not correlate with myocardial infarct size or area at risk.
Scientific reports2023 Apr 27PMID37106099doi:10.1038/s41598-023-34196-7via clinicaltrials gov reference derived + pubmed nct search
Remote ischemic conditioning reduces myocardial infarct size and edema in patients with ST-segment elevation myocardial infarction.
JACC. Cardiovascular interventions2015 Jan (month)PMID25240548doi:10.1016/j.jcin.2014.05.015via CT.gov reference
Intracoronary injection of adenosine before reperfusion in patients with ST-segment elevation myocardial infarction: a randomized controlled clinical trial.
International journal of cardiology2014 Dec 20PMID25449504doi:10.1016/j.ijcard.2014.09.203via CT.gov reference
Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction.
European heart journal2012 Jun (month)PMID21920963doi:10.1093/eurheartj/ehr309via CT.gov background
Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial.
Lancet (London, England)2010 Feb 27PMID20189026doi:10.1016/S0140-6736(09)62001-8via CT.gov reference

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.