STEMI (ST elevated Myocardial Infarction)
Conditions
Brief summary
The absolute change in left ventricular ejection fraction (LVEF), measured by transthoracic echocardiography (TTE), between 24 to 72 hours post-primary percutaneous coronary intervention (PPCI) and 6 months post-procedure. All assessments will be performed blinded to treatment group assignment.
Detailed description
Left ventricular regional wall motion score index (RWMSI) of the Infarct zone at 6 months, corrected for 24 to 72 hours post-PPCI RWMSI, assessed by 2D Transthoracic Echocardiography blinded to treatment group assignment., Primary safety endpoint formally tested for statistical significance is the Composite of device or procedure-related mortality, clinically driven target vessel/lesion revascularization, vessel dissection and IPTE (defined as the development of new or increasing thrombus, abrupt vessel closure, no reflow, slow reflow, and distal embolization at any point during the CoFI procedure) assessed at 30 days.
Interventions
DRUGTirofiban Ibisqus 50 Mikrogramm/ml Infusionslösung
Sponsors
Corflow Therapeutics AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute change in left ventricular ejection fraction (LVEF), measured by transthoracic echocardiography (TTE), between 24 to 72 hours post-primary percutaneous coronary intervention (PPCI) and 6 months post-procedure. All assessments will be performed blinded to treatment group assignment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Left ventricular regional wall motion score index (RWMSI) of the Infarct zone at 6 months, corrected for 24 to 72 hours post-PPCI RWMSI, assessed by 2D Transthoracic Echocardiography blinded to treatment group assignment., Primary safety endpoint formally tested for statistical significance is the Composite of device or procedure-related mortality, clinically driven target vessel/lesion revascularization, vessel dissection and IPTE (defined as the development of new or increasing thrombus, abrupt vessel closure, no reflow, slow reflow, and distal embolization at any point during the CoFI procedure) assessed at 30 days. | — |
Outcome results
None listed