FERRIC CARBOXYMALTOSE for Acute coronary syndrome

Inclusion criteria

• {"criterion_text":"- Patients aged 65 years or older.\n- Patients with a confirmed diagnosis of acute coronary syndrome (ACS) within a maximum of 15 days prior to inclusion.\n- Patients with a confirmed diagnosis of iron deficiency at the time of hospital admission or within 15 days after the cardiac event, untreated, and defined by: - Serum ferritin <100 ng/mL, or - Transferrin saturation (TSAT) <20%, according to the European Society of Cardiology guidelines and the SEC_SEMI consensus.\n- Ability to understand the study details and to provide written informed consent prior to any trial-related procedures."}

Exclusion criteria

• {"criterion_text":"- Patients with active cancer.\n- Patients with ongoing bacteremia.\n- Patients currently participating in other clinical trials involving investigational medicinal products.\n- Patients who, in the opinion of the investigator, should not participate in the study due to difficulties in complying with procedures, restrictions, or requirements.\n- Terminally ill patients as determined by the IDC-Pal score (Instrument for Diagnosing Complexity in Palliative Care).\n- Patients with a prior diagnosis of heart failure (HF) with a left ventricular ejection fraction (LVEF) <40%, or who develop this condition during hospitalization or within 15 days following the acute coronary syndrome (ACS) event will be excluded.\n- Patients undergoing dialysis, or with advanced hepatic or renal failure.\n- Patients with severe anemia (hemoglobin <10 g/dL) at the time of the event or within the subsequent 15 days.\n- Patients with previously diagnosed iron deficiency, identified and treated with intravenous or oral iron within the year prior to the event.\n- Patients with known hypersensitivity to intravenous iron or to any of the excipients in the product.\n- Patients with known severe hypersensitivity to other parenteral iron products.\n- Evidence of iron overload or disorders in iron utilization."}

Primary endpoints

• {"endpoint_text":"- Change in EQ-5D-5L score at 6 and 12 months vs. baseline (IV iron group vs. control).","definition_or_measurement_approach":"Change in health-related quality of life as measured by the EQ-5D-5L instrument at baseline, 6 months and 12 months; comparison between intravenous iron (IV iron) group and control group."}

Secondary endpoints

• {"endpoint_text":"- Change in FRAIL Scale score at 6 and 12 months vs. baseline.","definition_or_measurement_approach":"Change measured by the FRAIL Scale at baseline, 6 months and 12 months."}
• {"endpoint_text":"- Change in CRP and hs-CRP levels from baseline to 12 months.","definition_or_measurement_approach":"Change in inflammatory biomarkers (CRP and high-sensitivity CRP) measured in blood from baseline to 12 months."}
• {"endpoint_text":"- Incidence of decompensated heart failure requiring hospitalization (12 months).","definition_or_measurement_approach":"Occurrence of hospitalization for decompensated heart failure during the 12-month follow-up period, as documented in clinical records."}
• {"endpoint_text":"- Incidence of non-fatal myocardial infarction (1 year).","definition_or_measurement_approach":"Occurrence of non-fatal myocardial infarction within 1 year, based on clinical diagnosis and medical records."}
• {"endpoint_text":"- Incidence of stroke (1 year).","definition_or_measurement_approach":"Occurrence of stroke within 1 year, based on clinical diagnosis and medical records."}
• {"endpoint_text":"- All-cause mortality at 12 months.","definition_or_measurement_approach":"Death from any cause occurring within 12 months of baseline."}
• {"endpoint_text":"- Change in iron metabolism markers (iron, ferritin, serum ferritin, sTfR, TSAT, HIF-1, hepcidin) from baseline to 12 months (subgroup).","definition_or_measurement_approach":"Change in specified iron metabolism laboratory markers measured in a subgroup from baseline to 12 months."}
• {"endpoint_text":"- Change in inflammatory markers (CRP, hs-CRP, IL-1, IL-6, IL-10, IL-18, TNF-α) from baseline to 12 months (subgroup).","definition_or_measurement_approach":"Change in specified inflammatory biomarkers measured in a subgroup from baseline to 12 months."}
• {"endpoint_text":"- Change in biological age markers from baseline to 12 months (subgroup).","definition_or_measurement_approach":"Change in biomarkers of biological age measured in a subgroup from baseline to 12 months."}
• {"endpoint_text":"- Change in telomere length from baseline to 12 months (subgroup).","definition_or_measurement_approach":"Change in telomere length measured in a subgroup from baseline to 12 months."}
• {"endpoint_text":"- Correlation of baseline Klotho and FGF23 values with adverse clinical events (HF decompensation, reinfarction, stroke, all-cause mortality) at 12 months (subgroup).","definition_or_measurement_approach":"Correlation analysis between baseline Klotho and FGF23 biomarker levels and occurrence of specified adverse clinical events at 12 months in a subgroup."}

Spain

Earliest CTIS Part Ii Submission Date

06-10-2025

Latest Decision Or Authorization Date

03-12-2025

Processing Time Days

58

Number Of Sites

10

Number Of Participants

538

Primary sponsor

Full Name

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain