Amoxicillin trihydrate for Non-ST-elevation myocardial infarction | ST-elevation myocardial infarction | Coronary artery disease

Inclusion criteria

• {"criterion_text":"- Clinically diagnosed ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI)\n- Invasive strategy has been chosen, i.e. angiography is performed\n- Age ≥18 years\n- Informed consent has been obtained\n- at least 3 of following high risk criteria are met (hypertension, DM, moderate renal insufficiency eGFR<60ml/min, peripheral arterial disease ASO, multivessel coronary artery disease, previous myocardial infraction, previous stroke or TIA)"}

Exclusion criteria

• {"criterion_text":"- Cardiogenic shock\n- Probable finding of SCAD (spontaneous coronary dissection)\n- Definite coronary embolism\n- Severe valvular disease\n- On-going bleeding or very high bleeding risk\n- < 1 year life expectancy\n- On-going antibiotic therapy\n- Severe allergy to contrast agents or ASA\n- Allergy to cephalosporin\n- On-going methotrexate medication\n- Clinical diagnosis of Takotsubo syndrome\n- Pregnancy"}

Primary endpoints

• {"endpoint_text":"- Major adverse cardiac and cerebrovascular events (MACCE) in 12 months follow-up, including: cardiovascular death, myocardial infarction, hospitalization for NYHA IV heart failure, stroke or transient ischemic attack (TIA)","definition_or_measurement_approach":"MACCE measured as occurrence of the listed components within 12 months follow-up (cardiovascular death, myocardial infarction, hospitalization for NYHA IV heart failure, stroke or TIA)."}

Secondary endpoints

• {"endpoint_text":"- Individual components of the primary end point at 12 months","definition_or_measurement_approach":"Assessment of each component of MACCE separately at 12 months."}
• {"endpoint_text":"- MACCE at 3 months","definition_or_measurement_approach":"Occurrence of MACCE within 3 months follow-up."}
• {"endpoint_text":"- MACCE at 2 and 5 years","definition_or_measurement_approach":"Occurrence of MACCE within 2-year and 5-year follow-up periods."}

Finland

Earliest CTIS Part Ii Submission Date

23-06-2025

Latest Decision Or Authorization Date

27-08-2025

Processing Time Days

65

Number Of Sites

1

Number Of Participants

1070

Primary sponsor

Full Name

TAYS Sydaenkeskus Oy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland