Ferric carboxymaltose for Myocardial infarction | Iron deficiency

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Subject temperature >38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Documented liver diseases."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Pregnancy or lactation."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Severe, symptomatic valve disorder."}
• {"criterion_text":"- Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation)."}
• {"criterion_text":"- Body weight <50 kg."}
• {"criterion_text":"- Haemoglobin <8 g/dL or >15,5 g/dL."}
• {"criterion_text":"- Serum ferritin >400 ng/mL."}
• {"criterion_text":"- Active gastroenteral bleeding."}
• {"criterion_text":"- Known hypersensitivity to any of the administered preparations."}
• {"criterion_text":"- Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation."}

Primary endpoints

• {"endpoint_text":"- 1) Time to all-cause death assessed up to maximum 36-months follow-up;","definition_or_measurement_approach":"Time-to-event analysis for all-cause mortality assessed up to a maximum of 36 months of follow-up."}
• {"endpoint_text":"- 2) Number of HFE assessed up to maximum 36-months follow-up;","definition_or_measurement_approach":"Count of heart failure events (HFE) during follow-up up to 36 months. HFE defined as unplanned hospitalization for HF (including unplanned ED visit due to HF), ambulatory significant intensification of diuretic therapy (starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms)."}
• {"endpoint_text":"- 3) Time to first HFE assessed up to maximum 36-months follow-up;","definition_or_measurement_approach":"Time-to-first heart failure event (HFE) up to 36 months; HFE defined as above."}
• {"endpoint_text":"- 4) Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve;","definition_or_measurement_approach":"Change in NT-proBNP levels from baseline to end of participation assessed using area under the curve (AUC) over the follow-up period."}
• {"endpoint_text":"- 5) Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve.","definition_or_measurement_approach":"Change in QoL measured by EQ-5D from baseline to end of participation assessed using area under the curve (AUC)."}

Secondary endpoints

• {"endpoint_text":"- First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up (time-to-event model).","definition_or_measurement_approach":"Time-to-event model for first occurrence of composite outcome: unplanned HF hospitalization, unplanned ED visit due to HF, or cardiovascular death."}
• {"endpoint_text":"- All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up (recurrent event model).","definition_or_measurement_approach":"Recurrent event model counting all unplanned HF hospitalisations, unplanned ED visits due to HF, and cardiovascular deaths during follow-up."}
• {"endpoint_text":"- All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up (recurrent event model).","definition_or_measurement_approach":"Recurrent event model counting all unplanned HF hospitalisations and unplanned ED visits due to HF during follow-up."}
• {"endpoint_text":"- All unplanned HF hospitalisations during the follow-up (recurrent event model).","definition_or_measurement_approach":"Recurrent event model counting all unplanned HF hospitalisations during follow-up."}
• {"endpoint_text":"- CV death during thefollow-up.","definition_or_measurement_approach":"Cardiovascular death during follow-up (time-to-event)."}

Poland

Earliest CTIS Part Ii Submission Date

07-10-2024

Latest Decision Or Authorization Date

18-11-2024

Processing Time Days

42

Number Of Sites

32

Number Of Participants

1000

Primary sponsor

Full Name

Wroclaw Medical University

Organisation Type

Educational Institution

Country Of Registered Address

Poland