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RECRUITING
NCT07476859
PHASE4

Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome

Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

View on ClinicalTrials.gov

Summary

The goal of this phase IV, open-label, randomized clinical trial is to evaluate whether intravenous iron improves quality of life in adults aged 65 years and older with iron deficiency after an acute coronary syndrome (ACS). The main questions it aims to answer are: * Does intravenous iron improve quality of life at 6 and 12 months? * Does it reduce frailty and adverse clinical outcomes? Researchers will compare intravenous ferric carboxymaltose with standard of care. Participants will: * Be randomly assigned to receive intravenous iron or standard care * Attend three study visits over 12 months * Complete questionnaires and undergo blood tests

Official title: Phase IV, Open-label, Randomized Clinical Trial on the Effect of Intravenous Iron on Quality of Life in Elderly Patients With Acute Coronary Syndrome

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

538

Start Date

2026-03-05

Completion Date

2028-05

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

DRUG

Ferric Carboxymaltose Injection [Ferinject]

Intervention Description (Treatment Arm) Single intravenous administration of ferric carboxymaltose (Ferinject®) given at baseline within 15 days after the index acute coronary syndrome. The total iron dose is individually calculated according to body weight and hemoglobin levels, in accordance with the approved Summary of Product Characteristics (maximum 15 mg/kg, not exceeding 2,000 mg). The drug is administered in a monitored hospital setting. No additional iron doses are planned during follow-up. Intervention Description (Control Arm) Standard post-acute coronary syndrome care without specific treatment for iron deficiency. No intravenous or oral iron supplementation is administered per protocol.

Locations (9)

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital Universitario de Badajoz

Badajoz, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Universitario Clínico San Cecilio

Granada, Spain

Hospital Universitario de León

León, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain