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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Age ≥ 65 years.

• Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment.

• Iron deficiency diagnosed at admission or within 15 days after the index ACS event, defined as:

‣ Serum ferritin \< 100 ng/mL, OR

⁃ Transferrin saturation (TSAT) \< 20%.

• Ability to provide written informed consent prior to participation.

Locations
Other Locations
Spain
Hospital Universitario de Badajoz
RECRUITING
Badajoz
Hospital Clínic de Barcelona
NOT_YET_RECRUITING
Barcelona
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING
El Palmar
Hospital Universitario Clínico San Cecilio
RECRUITING
Granada
Hospital Universitario de León
NOT_YET_RECRUITING
León
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario de Navarra
NOT_YET_RECRUITING
Pamplona
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Hospital Álvaro Cunqueiro
NOT_YET_RECRUITING
Vigo
Contact Information
Primary
Clara Bonanad Lozano, Doctor
clarabonanad@gmail.com
+34 686 10 70 71
Backup
Claudio Rivadulla Varela, Doctor
c.rivare@hotmail.com
+34 625 11 46 86
Time Frame
Start Date: 2026-03-05
Estimated Completion Date: 2028-05
Participants
Target number of participants: 538
Treatments
Experimental: Intervention arm
Intravenous iron administered according to protocol and SmPC.
No_intervention: Control arm
No specific intervention for iron deficiency (standard of care post-acute coronary syndrome)
Related Therapeutic Areas
Sponsors
Collaborators: AstraZeneca
Leads: Fundación para la Investigación del Hospital Clínico de Valencia

This content was sourced from clinicaltrials.gov