COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial

Last updated: November 2, 2020
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Angina

Heart Defect

Treatment

N/A

Clinical Study ID

NCT02404376
COMBAT-MI
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 orpresumed 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, aVLleads) and V4-V6.
  • Patients presenting within 6 hours of chest pain.

Exclusion

Exclusion Criteria:

  • Known hypersensitivity to exenatide or any of the excipients
  • Known contraindication to CMR imaging such as significant claustrophobia, severeallergy to gadolinium chelate contrast, severe renal insufficiency (defined asestimated glomerular filtration rate [eGFR] (epidermal growth factor receptor) <30mL/min/1.73 m2), presence of CMRI contraindicated implanted devices (e.g., pacemaker,implanted cardiac defibrillator, cardiac resynchronization therapy device, cochlearimplant), embedded metal objects (e.g., shrapnel), or any other contraindication forCMRI.
  • Assumed life expectancy < 1 year e.g. due to non-cardiac disease.
  • TIMI flow grade > 1 at the time of diagnostic coronary angiography. These patientswill be excluded from the analysis of infarct size but will be included in the safetyanalysis.
  • Pregnant women
  • Patients with loss of consciousness or confused, not able to read the information andto sign the writting consent
  • Patients with oro-tracheal intubation
  • Patients with cardiogenic shock persisting 48h after reperfusion

Study Design

Total Participants: 378
Study Start date:
March 01, 2016
Estimated Completion Date:
June 30, 2020

Study Description

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.

Connect with a study center

  • Hopital cardiologique Louis Pradel

    Bron, 69677
    France

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Universitario Arnau de Vilanova

    Lerida, Barcelona 25198
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, La Coruña 15706
    Spain

    Site Not Available

  • Hospital Universitario Valle de Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitari de Girona Josep Trueta

    Girona, 17007
    Spain

    Site Not Available

  • Hospital Universitario Arnau de Vilanova

    Lleida, 25198
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitari de Tarragona Joan 23

    Tarragona, 43005
    Spain

    Site Not Available

  • Hospital The Hatter Cardiovascular Institute

    London, WC1E 6HX
    United Kingdom

    Site Not Available

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