METFORMIN for Acute coronary syndrome

Inclusion criteria

• {"criterion_text":"- Age >18 years\n- First episode of the ACS in accordance with ESC (European Society of Cardiology) treating with percutaneous coronary intervention with drug-eluting stent implantation\n- Profession, place of residence (but close enough that it will not cause difficulty in monitoring during research)\n- Uncomplicated course of the disease (ACS) as assessed by the treating physician\n- Patient negative history of diabetes\n- No hypoglycemic drugs before the admission or in the last 6 months\n- HbA1c< 6,5% (assessment during hospitalization)\n- Written consent to participate in the study"}

Exclusion criteria

• {"criterion_text":"- Significant valvular disease confirmed in ECHO\n- Pregnancy and breast - breeding\n- Patient participation in another study\n- History of previous CABG\n- NYHA IV during hospitalization\n- Chronic kidney disease with GFR< 60 ml/min/1,73 m2 modo MDRD\n- ALT three times over UNL (upper normal limit) according to the laboratory criteria\n- Serious co-morbidity and estimated survival time of less than 2.5 years- as assessed by the treating physician\n- 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\"\n- Known potential difficulties in collaboration with patients (dementia, mental disorders, distance from patients residence if considered as potentially problematic, alcoholism)\n- Hypersensivity to metformin"}

Primary endpoints

• {"endpoint_text":"- The need to perform unplanned PCI or CABG after successful last stage of full revascularization because of ACS","definition_or_measurement_approach":"Measured as the need to perform unplanned PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period."}

Secondary endpoints

• {"endpoint_text":"- Cardiac death after successful final stage of revascularization due to ACS in the 30-month follow-up period","definition_or_measurement_approach":"Cardiac death occurring after successful final revascularization due to ACS measured during the 30-month follow-up."}
• {"endpoint_text":"- Death from any cause after successful final stage of revascularization due to ACS in the 30-month follow-up period","definition_or_measurement_approach":"All-cause mortality after successful final revascularization due to ACS measured during the 30-month follow-up."}
• {"endpoint_text":"- Non-fatal myocardial infarction after successful final stage of revascularization due to ACS in the 30-month follow-up period","definition_or_measurement_approach":"Non-fatal myocardial infarction after successful final revascularization due to ACS measured during the 30-month follow-up."}
• {"endpoint_text":"- Non-fatal stroke after successful final stage of revascularization due to ACS in the 30-month follow-up period","definition_or_measurement_approach":"Non-fatal stroke after successful final revascularization due to ACS measured during the 30-month follow-up."}

Poland

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

18-11-2024

Processing Time Days

38

Number Of Sites

24

Number Of Participants

1000

Primary sponsor

Full Name

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Soft Communication Danuta Moreń","duties_or_roles":"Trainings; registration in EUDRACT etc.; SIVs and COVs; Archiving (sponsor duties codes present)","organisation_type":"Industry"}