Actively Recruiting
Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome
Led by Fundación para la Investigación del Hospital Clínico de Valencia · Updated on 2026-03-24
538
Participants Needed
9
Research Sites
112 weeks
Total Duration
On this page
Sponsors
F
Fundación para la Investigación del Hospital Clínico de Valencia
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Hospitalized for confirmed acute coronary syndrome within 15 days before enrollment
- Iron deficiency diagnosed by serum ferritin less than 100 ng/mL or transferrin saturation less than 20%
- Ability to provide written informed consent
You will not qualify if you...
- Active cancer
- End-stage or terminal illness based on IDC-Pal score
- Heart failure with left ventricular ejection fraction below 40% before or within 15 days after ACS
- Chronic dialysis or advanced kidney or liver failure
- Severe anemia with hemoglobin below 10 g/dL at or within 15 days after ACS
- Previous intravenous or oral iron treatment within 12 months before ACS
- Known allergy to ferric carboxymaltose or related iron products
- Evidence of iron overload or iron metabolism disorders
- Ongoing bloodstream infection or active systemic infection
- Participation in another clinical trial with an investigational drug
- Any condition that could affect safety, protocol adherence, or study integrity as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
2
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Not Yet Recruiting
3
Hospital Universitario de Badajoz
Badajoz, Spain, 06080
Actively Recruiting
4
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Not Yet Recruiting
5
Hospital Universitario Clínico San Cecilio
Granada, Spain, 18016
Actively Recruiting
6
Hospital Universitario de León
León, Spain, 24071
Not Yet Recruiting
7
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
8
Hospital Universitario de Navarra
Pamplona, Spain, 31008
Not Yet Recruiting
9
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
C
Clara Bonanad Lozano, Doctor
CONTACT
C
Claudio Rivadulla Varela, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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