Acute anterior myocardial infarction with systolic dysfunction.
Conditions
Brief summary
Primary efficacy study endpoint: - Echocardiographic evidence of LVT at the any of the following time points: 24 hours (Day 1), 72 hours (Day 3), 240 hours (day 10) and Day 30 (follow-up visit). Primary safety study endpoint: - Bleedings BARC 3-5 at 30 days.
Detailed description
Secondary efficacy study endpoints: - In CMR sub-study: the presence of LVT at 10 days (+ 2 days) from the anterior STEMI. - CMR sub-study: agreement between contrast-enhanced echocardiography and CMR. - In case CMR is available, volume/mass thrombus measurements in pts with evidence of LVT. - Thromboembolic events, CV mortality, all-cause mortality at 30 days. - BARC type 2 bleeding and any BARC ≥2 bleeding. - Comp
Interventions
DRUGACETYLSALICYLIC ACID
DRUGPRASUGREL
DRUGArixtra 2.5 mg/0.5 ml solution for injection
DRUGCLOPIDOGREL
DRUGTICAGRELOR
Sponsors
Azienda Unita' Sanitaria Locale Toscana Sud Est
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy study endpoint: - Echocardiographic evidence of LVT at the any of the following time points: 24 hours (Day 1), 72 hours (Day 3), 240 hours (day 10) and Day 30 (follow-up visit). Primary safety study endpoint: - Bleedings BARC 3-5 at 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy study endpoints: - In CMR sub-study: the presence of LVT at 10 days (+ 2 days) from the anterior STEMI. - CMR sub-study: agreement between contrast-enhanced echocardiography and CMR. - In case CMR is available, volume/mass thrombus measurements in pts with evidence of LVT. - Thromboembolic events, CV mortality, all-cause mortality at 30 days. - BARC type 2 bleeding and any BARC ≥2 bleeding. - Comp | — |
Outcome results
None listed