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

NCT07476859 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2026-03-24

No results posted yet for this study

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

Conditions

  • Acute Coronary Syndromes (ACS)
  • Iron Deficiencies
  • Elderly (People Aged 65 or More)

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Fundación para la Investigación del Hospital Clínico de Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-05
Primary Completion
2028-04-30
Completion
2028-05-31

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07476859 on ClinicalTrials.gov