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COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial

NCT ID: NCT02404376

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-06-30

Brief Summary

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Remote ischemic conditioning (RIC) and intravenous exenatide administered immediately before primary angioplasty have been found to limit infarct size in patients with STEMI (ST segment elevation myocardial infarction), but the reduction is limited. This study investigates whether a combination therapy including both therapies is more effective.

Detailed Description

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COMBAT-MI is an investigator-driven, randomized, double-blind and placebo-controlled clinical trial aimed at evaluating the effect of Remote Ischemic Conditioning and exenatide, alone and in combination, on Myocardial Infarct size in 428 STEMI patients (107 per group) (ST segment elevation myocardial infarction). Patients with TIMI (Thrombolysis in Myocardial Infarction) flow grade \> 1 will be excluded. The study has a 2 x 2 factorial design (Remote Ischemic Conditioning , Exenatide, both or neither). The primary end-point will be Myocardial Infarct size measured by Cardiac Magnetic Resonance Imaging (CMRI) performed 3 - 7 days after primary Percutaneous Coronary Intervention (pPCI) (expressed as % of left ventricular (LV) mass). Sample size has been calculated in 274 patients with TIMI 0-1 available for analysis of the primary end-point, and inclusion will end when this number is reached, which will require, according to the current rate of TIMI 0-1 in our STEMI population, to randomize 428 patients. Secondary end-points will include myocardial salvage index, based on angiographic and CMRI derived estimations of the area at risk, and frequency of Major Adverse Cardiovascular Events (MACE) and of major adverse events during admission.

Conditions

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ST Elevation Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Remote Ischemic Conditioning

Remote Ischemic Conditioning + placebo

Group Type ACTIVE_COMPARATOR

Remote Ischemic Conditioning (RIC)

Intervention Type OTHER

Remote ischemic conditioning with a cuff in the arm

Placebo

Intervention Type DRUG

Intrevenous administration of Placebo

Combined treatment

Remote Ischemic Conditioning + exenatide

Group Type ACTIVE_COMPARATOR

Exenatide

Intervention Type DRUG

Intravenous administration of Exenatide

Remote Ischemic Conditioning (RIC)

Intervention Type OTHER

Remote ischemic conditioning with a cuff in the arm

Placebo

Sham Remote Ischemic Conditioning + placebo

Group Type PLACEBO_COMPARATOR

Remote Ischemic Conditioning (RIC)

Intervention Type OTHER

Remote ischemic conditioning with a cuff in the arm

Placebo

Intervention Type DRUG

Intrevenous administration of Placebo

Exenatide

Sham Remote Ischemic Conditioning + exenatide

Group Type ACTIVE_COMPARATOR

Exenatide

Intervention Type DRUG

Intravenous administration of Exenatide

Remote Ischemic Conditioning (RIC)

Intervention Type OTHER

Remote ischemic conditioning with a cuff in the arm

Interventions

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Exenatide

Intravenous administration of Exenatide

Intervention Type DRUG

Remote Ischemic Conditioning (RIC)

Remote ischemic conditioning with a cuff in the arm

Intervention Type OTHER

Placebo

Intrevenous administration of Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ignacio Ferreira González, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca

Locations

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Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, La Coruña, Spain

Site Status

Hospital Universitario Valle de Hebron

Barcelona, , Spain

Site Status

Hospital Universitario Arnau de Vilanova

Lleida, , Spain

Site Status

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Universitari de Tarragona Joan 23

Tarragona, , Spain

Site Status

Countries

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Spain

References

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Lonborg J, Vejlstrup N, Kelbaek H, Botker HE, Kim WY, Mathiasen AB, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Thuesen L, Krusell LR, Jensen JS, Kober L, Treiman M, Holst JJ, Engstrom T. Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2012 Jun;33(12):1491-9. doi: 10.1093/eurheartj/ehr309. Epub 2011 Sep 14.

Reference Type BACKGROUND
PMID: 21920963 (View on PubMed)

Botker HE, Kharbanda R, Schmidt MR, Bottcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sorensen HT, Redington AN, Nielsen TT. 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. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8.

Reference Type RESULT
PMID: 20189026 (View on PubMed)

White SK, Frohlich GM, Sado DM, Maestrini V, Fontana M, Treibel TA, Tehrani S, Flett AS, Meier P, Ariti C, Davies JR, Moon JC, Yellon DM, Hausenloy DJ. Remote ischemic conditioning reduces myocardial infarct size and edema in patients with ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):178-188. doi: 10.1016/j.jcin.2014.05.015. Epub 2014 Sep 17.

Reference Type RESULT
PMID: 25240548 (View on PubMed)

Garcia-Dorado D, Garcia-del-Blanco B, Otaegui I, Rodriguez-Palomares J, Pineda V, Gimeno F, Ruiz-Salmeron R, Elizaga J, Evangelista A, Fernandez-Aviles F, San-Roman A, Ferreira-Gonzalez I. Intracoronary injection of adenosine before reperfusion in patients with ST-segment elevation myocardial infarction: a randomized controlled clinical trial. Int J Cardiol. 2014 Dec 20;177(3):935-41. doi: 10.1016/j.ijcard.2014.09.203. Epub 2014 Oct 7.

Reference Type RESULT
PMID: 25449504 (View on PubMed)

Consegal M, Barba I, Garcia Del Blanco B, Otaegui I, Rodriguez-Palomares JF, Marti G, Serra B, Bellera N, Ojeda-Ramos M, Valente F, Carmona MA, Miro-Casas E, Sambola A, Lidon RM, Baneras J, Barrabes JA, Rodriguez C, Benito B, Ruiz-Meana M, Inserte J, Ferreira-Gonzalez I, Rodriguez-Sinovas A. 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. Sci Rep. 2023 Apr 27;13(1):6907. doi: 10.1038/s41598-023-34196-7.

Reference Type DERIVED
PMID: 37106099 (View on PubMed)

Other Identifiers

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COMBAT-MI

Identifier Type: -

Identifier Source: org_study_id