Acute coronary syndrome MedDRA version: 20.0 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: HLGT Classification code 10011082 Term: Coronary artery disorders System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: HLT Classification code 10011085 Term: Ischaemic coronary artery disorders System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classificati
Conditions
Interventions
Trade Name: GLUCOPHAGE 500 mg
Product Name: Metformin
Pharmaceutical Form: Tablet
Trade Name: GLUCOPHAGE 850 mg
Product Name: Metformin
Pharmaceutical Form: Tablet
Sponsors
Wojskowy Instytut Medyczny
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: IC-1 Age >18 years IC-2 First episode of the ACS in accordance with ESC (European Society of Cardiology) treating with percutaneous coronary intervention with drug-eluting stent implantation IC-3 Profession, place of residence (but close enough that it will not cause difficulty in monitoring during research) IC-4 Uncomplicated course of the disease (ACS) as assessed by the treating physician IC-5 Patient negative history of diabetes IC-6 No hypoglycemic drugs before the admission or in the last 6 months IC-7 HbA1c=65 years) yes F.1.3.1 Number of subjects for this age range 330
Exclusion criteria
Exclusion criteria: EC-1. Significant valvular disease confirmed in ECHO EC-2. History of previous CABG EC-3. NYHA IV during hospitalization EC-4. Chronic kidney disease with GFR< 60 ml/min/1,73 m2 modo MDRD EC-5. ALT three times over UNL (upper normal limit) according to the laboratory criteria EC-6. Serious co-morbidity and estimated survival time of less than 2.5 years- as assessed by the treating physician EC-7. Known gastro-intestinal disease which could be potentially responsible for metformin intolerance (eg inflammatory bowel disease, GERD- gastro-esophageal reflux disease)- this criterion only for patients from “treatment group” EC-8. Known potential difficulties in collaboration with patients (dementia, mental disorders, distance from patients residence if considered as potentially problematic, alcoholism) EC-9. Hypersensivity to metformin EC-10. Pregnancy and breast - breeding EC-11. Patient participation in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effect of metformin in reducing the rate of unplanned coronary revascularization in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome.;Secondary Objective: 1. To evaluate the effects of metformin on other major cardiovascular events in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome. 2. To assess the safety of metformin use in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome.;Primary end point(s): 1. The need to perform unplanned PCI or CABG after successful last stage of full revascularization because of ACS;Timepoint(s) of evaluation of this end point: 1. The need to perform unplanned PCI or CABG after successful last stage of full revascularization because of ACS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Cardiac death after successful final stage of revascularization due to ACS in the 30-month follow-up period 2. Death from any cause after successful final stage of revascularization due to ACS in the 30-month follow-up period 3. Non-fatal myocardial infarction after successful final stage of revascularization due to ACS in the 30-month follow-up period 4. Non-fatal stroke after successful final stage of revascularization due to ACS in the 30-month follow-up period ;Timepoint(s) of evaluation of this end point: 1. The percentage of cardiac deaths after successful final stage of revascularization due to ACS in the 30-month follow-up period 2. All-cause death rate after successful final stage of revascularization due to ACS in the 30-month follow-up period 3. The percentage of non-fatal myocardial infarctions after successful final stage of revascularization due to ACS in the 30-month follow-up period 4. Percentage of non-fatal strokes after successful final stage of revascularization due to ACS in the 30-month follow-up period 5. To assess the safety profile of metformin in this patient population based on the rate of adverse events recorded | — |
Countries
Poland
Contacts
Public ContactWojskowy Instytut Medyczny
Wojskowy Instytut Medyczny
Outcome results
None listed