"MetCool ACS"- Metformin "Cooling" Effect on Metformin-naive Patients Treated With PCI Because of Acute Coronary Syndrome

Last updated: March 23, 2022
Sponsor: Military Institute of Medicine, Poland
Overall Status: Active - Recruiting

Phase

3

Condition

Chest Pain

Cardiac Ischemia

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT05305898
MC-ACS01-2020
2020-004962-21
  • Ages > 18
  • All Genders

Study Summary

The aim of the study is the evaluation of the effect of metformin among the patients without diabetes, on the incidence of reintervention, unplanned revascularization, after full percutaneous coronary revascularization as a result of the first episode of the acute coronary syndrome (ACS).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18 years
  • ACS, according to the current definition of the European Society of Cardiology,treated with percutaneous coronary intervention with drug eluting stent implantation
  • Occupation and place of residence not causing difficulties in participating in controlvisits
  • Uncomplicated course of the disease (ACS) as assessed by the treating physician
  • Negative history of diabetes
  • Not taking any hypoglycaemic drugs prior to hospitalization immediately or within thelast 6 months
  • HbA1c< 6,5% (assessment during hospitalization)
  • Written consent to participate in the study

Exclusion

Exclusion Criteria:

  • Significant valve disease confirmed by ECHO
  • Previous CABG
  • NYHA IV during hospitalization
  • Chronic kidney disease with GFR <60 ml / min / 1.73 m2 according to MDRD
  • ALT three times above normal according to laboratory criteria
  • Serious co-morbidities and estimated survival less than 2.5 years, as assessed by thetreating physician
  • Known gastrointestinal disease that may potentially be responsible for the intoleranceto metformin (e.g. inflammatory bowel disease, gastro-oesophageal reflux disease)
  • Known potential difficulties in cooperation with patients (dementia, mental disorders,distance from the place of residence, if considered potentially problematic,alcoholism)
  • Hypersensitivity to metformin
  • Pregnancy and breastfeeding
  • Patient participation in another clinical trial

Study Design

Total Participants: 2000
Study Start date:
February 08, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wielkopolskim

    Gorzów Wielkopolski, Lubuskie 66-400
    Poland

    Site Not Available

  • Wojskowy Instytut Medyczny

    Warszawa, Mazowieckie 04-141
    Poland

    Active - Recruiting

  • Oddział Kardiologii Szpitala św. Rafała

    Kraków, Małopolskie 30-693
    Poland

    Site Not Available

  • Kluczborskie Centrum Kardiologii

    Kluczbork, Opolskie 46-200
    Poland

    Site Not Available

  • Centrum Kardiologii Scanmed w Bielsku Podlaskim

    Bielsk Podlaski, Podlaskie 17-100
    Poland

    Site Not Available

  • Centrum Kardiologii Scanmed w Ełku

    Ełk, Warmińsko-Mazurskie 19-300
    Poland

    Site Not Available

  • Centrum Kardiologii Scanmed w Iławie

    Iława, Warmińsko-Mazurskie 14-202
    Poland

    Site Not Available

  • Centrum Kardiologii Scanmed w Szczecinku

    Szczecinek, Zachodniopomorskie 78-400
    Poland

    Site Not Available

  • Centrum Kardiologii Scanmed w Kutnie

    Kutno, Łódzkie 99-320
    Poland

    Site Not Available

  • Centrum Kardiologii Scanmed w Tomaszowie Mazowieckim

    Tomaszów Mazowiecki, Łódzkie 97-200
    Poland

    Site Not Available

  • Częstochowskie Centrum Kardiologii

    Częstochowa, Śląske 42-200
    Poland

    Site Not Available

  • Chorzowskie Centrum Kardiologii

    Chorzów, Śląskie 41-500
    Poland

    Site Not Available

  • Raciborskie Centrum Medyczne

    Racibórz, Śląskie 47-400
    Poland

    Site Not Available

  • Sosnowieckie Centrum Kardiologii

    Sosnowiec, Śląskie 41-219
    Poland

    Site Not Available

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