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

Study Overview
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Brief Summary
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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).

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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin group<br>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. | Drug: Metformin<br>* 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.<br>|
| No Intervention: No metformin group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for unscheduled PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period | Number of patients who needs an unscheduled PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period | through study completion, an average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from cardiac causes after successful final stage of revascularization due to ACS within 30 months of follow-up | Number of deaths from cardiac causes after successful final stage of revascularization due to ACS within 30 months of follow-up | through study completion, an average of 5 years | 
| All-cause death following successful final stage revascularization for ACS within a 30-month follow-up period | Number of all-cause deaths following successful final stage revascularization for ACS within a 30-month follow-up period | through study completion, an average of 5 years | 
| Non-fatal myocardial infarction after successful final stage of revascularization due to ACS within 30 months of follow-up | Number of non-fatal myocardial infarctions after successful final stage of revascularization due to ACS within 30 months of follow-up | through study completion, an average of 5 years | 
| Non-fatal stroke after successful final stage of revascularization due to ACS within 30 months of follow-up | Number of non-fatal strokes after successful final stage of revascularization due to ACS within 30 | through study completion, an average of 5 years |