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

  • STATUS
    Recruiting
  • End date
    Dec 21, 2025
  • participants needed
    2000
  • sponsor
    Military Institute of Medicine, Poland
Updated on 21 April 2022
diabetes
hba1c
percutaneous coronary intervention
acute coronary syndrome
coronary revascularization

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).

Details
Condition Acute Coronary Syndrome
Treatment Metformin
Clinical Study IdentifierNCT05305898
SponsorMilitary Institute of Medicine, Poland
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

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 control visits
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 the last 6 months
HbA1c< 6,5% (assessment during hospitalization)
Written consent to participate in the study

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 the treating physician
Known gastrointestinal disease that may potentially be responsible for the intolerance to 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
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