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2024-516589-13-00RecruitingPhase 3

"MetCool ACS"- Metformin "Cooling" Effect on metformin-naive Patients Treated with PCI because of Acute Coronary Syndrome

Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Jul 2026

Next steps

Brief summary (registry, in English)

The primary objective of the study is to evaluate the effect of metformin in reducing the rate of unplanned coronary revascularization in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
17 Sept 2024
Start date
18 Nov 2024
Lead sponsor
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
EU CT number
2024-516589-13-00
EudraCT number
2020-004962-21

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1000
  • 26 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults without diabetes who had a first acute coronary syndrome and were treated with a stent. It tests whether metformin lowers the need for repeat procedures.

Age
Over 18 years
Sex
All sexes
Disease stage
First episode of acute coronary syndrome, treated with percutaneous coronary intervention with a drug-eluting stent, with an uncomplicated course as judged by the treating doctor.
Earlier treatment
No drugs to lower blood sugar before admission or in the last 6 months.
Biomarker or test result
HbA1c below 6,5% (measured during the hospital stay). No history of diabetes.

Main reasons for not taking part

  • Significant valvular disease on ECHO
  • Pregnancy or breast-feeding
  • Previous CABG (bypass surgery)
  • Chronic kidney disease with GFR below 60 ml/min/1,73 m2
  • Hypersensitivity to metformin

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of previous CABG

Other illness

  • Significant valvular disease confirmed in ECHO
  • Known gastro-intestinal disease which could be potentially responsible for metformin intolerance (eg inflammatory bowel disease, GERD- gastro-esophageal reflux disease)- this criterion only for patients from "treatment group"
  • Known potential difficulties in collaboration with patients (dementia, mental disorders, distance from patients residence if considered as potentially problematic, alcoholism)

Lab values

  • Chronic kidney disease with GFR< 60 ml/min/1,73 m2 modo MDRD
  • ALT three times over UNL (upper normal limit) according to the laboratory criteria

Other

  • Pregnancy and breast - breeding
  • Patient participation in another study
  • NYHA IV during hospitalization
  • Serious co-morbidity and estimated survival time of less than 2.5 years- as assessed by the treating physician
  • Hypersensivity to metformin

Who the study is looking for

  • Age >18 years
  • First episode of the ACS in accordance with ESC (European Society of Cardiology) treating with percutaneous coronary intervention with drug-eluting stent implantation
  • Profession, place of residence (but close enough that it will not cause difficulty in monitoring during research)
  • Uncomplicated course of the disease (ACS) as assessed by the treating physician
  • Patient negative history of diabetes
  • No hypoglycemic drugs before the admission or in the last 6 months
  • HbA1c< 6,5% (assessment during hospitalization)
  • Written consent to participate in the study

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (26)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
American Heart of Poland S.A.Bielsko-BialaPolandRecruiting
Centrum Kardiologii Scanmed w Bielsku PodlaskimBielsk PodlaskiPolandRecruiting
Scanmed S.A.ChorzowPolandRecruiting
Małopolskie Centrum Sercowo-Naczyniowe AhoPChrzanówPolandRecruiting
Scanmed S.A.CzestochowaPolandRecruiting
American Heart of Poland S.A.Dąbrowa GórniczaPolandRecruiting
Centrum Kardiologii Scanmed w EłkuEłkPolandRecruiting
Uniwersyteckie Centrum KliniczneGdanskPolandRecruiting
Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wlkp. Spółka z Ograniczoną OdpowiedzialnościąGorzów WlkpPolandRecruiting
Centrum Kardiologii Scanmed w IławieIławaPolandRecruiting
Scanmed S.A.KluczborkPolandRecruiting
Szpital sw. Rafala Scanmed SAKrakowPolandRecruiting
4Cardia Szpital Kardiologii Inwazyjnej z Oddziałem Chirurgii NaczyniowejKraśnikPolandRecruiting
Scanmed S.A.KutnoPolandRecruiting
Wojskowy Instytut Medyczny - Szpital w LegionowieLegionowoPolandRecruiting
NZOZ Pomorskie Centra KardiologiczneMrągowoPolandRecruiting
Uniwersytecki Szpital Kliniczny w PoznaniuPoznanPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W PulawachPulawyPolandRecruiting
Centrum Kardiologii Scanmed w RaciborzuRacibórzPolandRecruiting
Szpital Wojewódzki im. Prymasa Kardynała Stefana Wyszyńskiego w SieradzuSieradzPolandRecruiting
Centrum Kardiologii Scanmed w SosnowcuSosnowiecPolandRecruiting
Centrum Kardiologii Scanmed w SzczecinkuSzczecinekPolandRecruiting
Centrum Kardiologii Scanmed w Tomaszowie MazowieckimTomaszów MazowieckiPolandRecruiting
American Heart of Poland S.A.TychyPolandRecruiting
Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsawPolandRecruiting
American Heart of Poland S.A.ZgierzPolandRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.