Acute Coronary Syndrome
Conditions
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 revascularization as a result of the first episode of the acute coronary syndrome (ACS).
Interventions
DRUGMetformin
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.
Sponsors
ABM Industries
Military Institute od Medicine National Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death 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 | Number of deaths from cardiac causes after successful final stage of revascularization due to ACS within 30 months of follow-up |
| All-cause death following successful final stage revascularization for ACS within a 30-month follow-up period | through study completion, an average of 5 years | Number of all-cause deaths following successful final stage revascularization for ACS within a 30-month follow-up period |
| Non-fatal myocardial infarction after successful final stage of revascularization due to ACS within 30 months of follow-up | through study completion, an average of 5 years | Number of non-fatal myocardial infarctions after successful final stage of revascularization due to ACS within 30 months of follow-up |
| Non-fatal stroke after successful final stage of revascularization due to ACS within 30 months of follow-up | through study completion, an average of 5 years | Number of non-fatal strokes after successful final stage of revascularization due to ACS within 30 |
Countries
Poland
Contacts
Primary ContactPiotr Kwiatkowski
Outcome results
None listed