Status:
UNKNOWN
"MetCool ACS"- Metformin "Cooling" Effect on Metformin-naive Patients Treated With PCI Because of Acute Coronary Syndrome
Lead Sponsor:
Military Institute od Medicine National Research Institute
Collaborating Sponsors:
ABM Industries
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT05305898
Start Date
February 8 2022
End Date
December 1 2025
Last Update
March 31 2022
Active Locations (14)
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1
Oddział Kardiologii Szpitala św. Rafała
Krakow, Lesser Poland Voivodeship, Poland, 30-693
2
Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wielkopolskim
Gorzów Wielkopolski, Lubusz Voivodeship, Poland, 66-400
3
Wojskowy Instytut Medyczny
Warsaw, Masovian Voivodeship, Poland, 04-141
4
Kluczborskie Centrum Kardiologii
Kluczbork, Opole Voivodeship, Poland, 46-200