NCT07476859 Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome
| NCT ID | NCT07476859 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fundación para la Investigación del Hospital Clínico de Valencia |
| Condition | Acute Coronary Syndromes (ACS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 538 participants |
| Start Date | 2026-03-05 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 538 participants in total. It began in 2026-03-05 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age ≥ 65 years. 2. Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment. 3. 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%. 4. Ability to provide written informed consent prior to participation. Exclusion Criteria: 1. Active malignancy. 2. End-stage or terminal illness as determined by the IDC-Pal score. 3. Known heart failure with left ventricular ejection fraction (LVEF) \< 40% prior to enrollment, or development of LVEF \< 40% during hospitalization or within 15 days after ACS. 4. Chronic dialysis or advanced renal or hepatic failure. 5. Severe anemia (hemoglobin \< 10 g/dL) at the time of ACS or within 15 days after the event. 6. Prior treatment with intravenous or oral iron within 12 months before the index ACS. 7. Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation. 8. Evidence of iron overload or disorders of iron metabolism. 9. Ongoing bacteremia or active systemic infection. 10. Participation in another interventional clinical trial involving an investigational medicinal product. 11. Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07476859 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Acute Coronary Syndromes (ACS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07476859 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07476859 currently recruiting?
Yes, NCT07476859 is actively recruiting participants. Contact the research team at clarabonanad@gmail.com for enrollment information.
Where is the NCT07476859 trial being conducted?
This trial is being conducted at El Palmar, Spain, Vigo, Spain, Badajoz, Spain, Barcelona, Spain and 5 additional locations.
Who is sponsoring the NCT07476859 clinical trial?
NCT07476859 is sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. The trial plans to enroll 538 participants.