Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion

Inclusion Criteria:

1. Age ≥18 years;
2. Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks before randomisation;
3. Presence of iron deficiency (ID) defined as transferrin saturation TSAT<20% and/orserum ferritin <100 ng/mL assessed up to 4 weeks before randomisation;
4. Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: atleast one of a-c must be present):
5. LVEF ≤50%;
6. NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL forsubjects with atrial fibrillation;
7. Clinical features of congestion/volume overload (including Killip class II ormore) requiring i.v. loop diuretic use;
8. Diagnosis of diabetes mellitus (also de novo diagnosis);
9. Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis);
10. Multivessel coronary disease (regardless of completeness of revascularisationduring an index AMI);
11. Not complete revascularisation or/and no reperfusion (during an index AMI);
12. History of AMI (despite an index AMI);
13. eGFR <60 mL/min/1.73m2;
14. Age ≥70 years.
15. Written informed consent

Exclusion Criteria:

1. Subject temperature>38 ͦ C or any infection requiring antibiotic therapy within 48hours prior to randomisation;
2. Severe, symptomatic valve disorder;
3. Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiringhospitalisation within 4 weeks prior to randomisation).
4. Body weight <50 kg;
5. Haemoglobin <8 g/dL or >15 g/dL;
6. Serum ferritin >400 ng/mL;
7. TSAT >40 %;
8. Active gastroenteral bleeding;
9. Known hypersensitivity to any of the administered preparations;
10. Treatment with erythropoiesis stimulating factors, i.v. iron therapy or bloodtransfusion within 6 months prior to randomisation;
11. Subject has known active malignancy of any organ system, i.e. clinical evidence ofcurrent malignancy or not in stable remission for at least 3 years since completion oflast treatment with exception of non-invasive basal cell carcinoma, squamous cellcarcinoma of the skin or cervical intra-epithelial neoplasia;
12. Documented liver diseases; Participation in a device or drug trial within 3 monthsprior to randomisation or 5 half-lives, whichever period is longer, prior to thescreening visit;

14. Pregnancy or lactation; 15) Any situation that may prevent the test from beingperformed in accordance with the protocol, or the consent of the investigator to be givenin writing, including alcohol, drugs or any other substance overuse or addiction.