Acute myocardial infarction (AMI)
Conditions
Brief summary
Efficacy: Occurrence of death or non-fatal AMI after any study treatment self-administration. The outcome will be ranked from most to least severe: 1. Death (all causes)* 2. AMI with compromised electro-hemodynamics** 3. STEMI** 4 .High-risk NSTEMI** 5. NSTEMI with peak cardiac troponin > 10 × upper limit of normal** 6. None of the above within *7/**2 days after each treatment administration Only the worst outcome will be retained as the primary endpoint., Safety: Occurrence of type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition, within 2 days after study treatment administration.
Detailed description
Occurrence of death, non-fatal AMI, hospitalization or unplanned emergency department visit for heart failure, within 30 days after any treatment administration (composite endpoint).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Occurrence of death or non-fatal AMI after any study treatment self-administration. The outcome will be ranked from most to least severe: 1. Death (all causes)* 2. AMI with compromised electro-hemodynamics** 3. STEMI** 4 .High-risk NSTEMI** 5. NSTEMI with peak cardiac troponin > 10 × upper limit of normal** 6. None of the above within *7/**2 days after each treatment administration Only the worst outcome will be retained as the primary endpoint., Safety: Occurrence of type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition, within 2 days after study treatment administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of death, non-fatal AMI, hospitalization or unplanned emergency department visit for heart failure, within 30 days after any treatment administration (composite endpoint). | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain