Ramipril for ST-elevation myocardial infarction | Myocardial ischemia

Inclusion criteria

• {"criterion_text":"- Patients with STEMI who undergo primary PCI within 6 hours of symptom onset* (*Excluding prodromal symptoms)\n- Informed consent"}

Exclusion criteria

• {"criterion_text":"- Killip class ≥ 3\n- Pre-existing non-reversible cardiac dysfunction or heart failure\n- Current treatment with any beta blocker, RAAS inhibitor or SGLT2 inhibitor\n- Absolute or relative contraindication to any one of the study drugs that confers a risk of patient safety if the patient participates in the trial and adheres to the protocol-specified recommendations, per the assessment of the treating physician\n- Life expectancy less than one year\n- Pregnancy or women of childbearing potential who is not sterilized or is not using a medically accepted form of contraception.\n- Additional exclusion criteria for the CMRI sub-study of the trial: 7. Any absolute contraindication for CMRI"}

Primary endpoints

• {"endpoint_text":"- Global longitudinal strain (GLS, %) at day 7±24 hours after PCI, adjusted for baseline (day 0) GLS.","definition_or_measurement_approach":"GLS (%) measured at day 7 ±24 hours after PCI, adjusted for baseline (day 0) GLS."}

Secondary endpoints

• {"endpoint_text":"- Left ventricular ejection fraction (LVEF), adjusted for baseline LVEF\n- NT-proBNP on day 7, adjusted for baseline NT-proBNP\n- Area under the curve of cardiac troponin-T at day 30\n- Area under the curve of cardiac troponin-I at day 30\n- Infarct size at 30 days (assessed by cardiac magnetic resonance imaging [CMRI])","definition_or_measurement_approach":"LVEF measured and adjusted for baseline LVEF; NT-proBNP measured on day 7 and adjusted for baseline; cardiac troponin-T and troponin-I AUC assessed up to day 30; infarct size assessed at 30 days by cardiac magnetic resonance imaging (CMRI)."}

Sweden

Earliest CTIS Part Ii Submission Date

05-06-2024

Latest Decision Or Authorization Date

27-06-2024

Processing Time Days

22

Number Of Sites

1

Number Of Participants

120

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Co-sponsors

• University Of Gothenburg