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

Korábbi kezelés

• Subject temperature >38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation;
• Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation).
• Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation;
• Subject has known active malignancy of any organ system, i.e., clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia;
• Participation in a device or drug trial within 3 months prior to randomisation or 5 half-lives, whichever period is longer, prior to the screening visit;
• Any situation that may prevent the test from being performed in accordance with the protocol, or the consent of the investigator to be given in writing, including alcohol, drugs or any other substance overuse or addiction.

Más betegség

• Severe, symptomatic valve disorder;
• Active gastroenteral bleeding;
• Known hypersensitivity to any of the administered preparations;
• Documented liver diseases;

Laborértékek

• Haemoglobin <8 g/dL or >15,5 g/dL;
• Serum ferritin >400 ng/mL;

Egyéb

• Body weight <50 kg;
• Pregnancy or lactation;

• Age ≥18 years;
• Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation
• Presence of iron deficiency (ID) defined as transferrin saturation TSAT<20% assessed within up to 4 weeks (28 days) before randomisation;
• Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present):
  • LVEF ≤50%;
  • NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation;
  • Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use;
  • Diagnosis of diabetes mellitus (also de novo diagnosis);
  • Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis);
  • Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI);
  • Not complete revascularisation or/and no reperfusion (during an index AMI);
  • History of AMI (despite an index AMI);
  • eGFR <60 mL/min/1.73m2; 1. Age ≥70 years.
• Written informed consent