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

Military Institute od Medicine National Research Institute

Status and phase: Enrolling; Phase 3

Conditions: Acute Coronary Syndrome

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT05305898

2020-004962-21 (EudraCT Number)

MC-ACS01-2020

Details and patient eligibility

About

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).

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Metformin group

Experimental group

Description:

Patients from "metformin group" will receive metformin 3 x 850 mg (after titration period) for 2 years (3 x 500 mg for first 6 weeks) with 6 months follow-up after treatment cessation.

Treatment:

Drug: Metformin

No metformin group

No Intervention group

Description:

Patients form "no metformin" group will be observed for 2 years and 6 months, which cover the same period like for patients from metformin group.