2025-522421-36-00RecruitingPhase 4
Effect of intravenous iron on quality of life in older adults with acute coronary syndrome: a phase IV clinical study
Phase IV, open-label, randomized clinical trial on the effect of intravenous iron on quality of life in elderly patients with Acute Coronary Syndrome.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Dec 2025
Brief summary (registry, in English)
To determine whether patients aged 65 years or older, diagnosed with iron deficiency after an acute coronary syndrome (ACS), who receive intravenous iron treatment have a better quality of life at 6 and 12 months of follow-up compared to patients who do not receive treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 538 (estimated)
- First submitted
- 23 Sept 2025
- Start date
- 27 Feb 2026
- Lead sponsor
- Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
- Diseases
- Coronary artery disease
- EU CT number
- 2025-522421-36-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 538
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 65 or older who had an acute coronary syndrome in the last 15 days and have iron deficiency that has not been treated.
- Age
- 65 years or older
- Sex
- All sexes can join.
- Disease stage
- Confirmed acute coronary syndrome within a maximum of 15 days before joining.
- Earlier treatment
- The iron deficiency must be untreated. People treated with intravenous or oral iron in the year before the event cannot join.
- Biomarker or test result
- Iron deficiency shown by serum ferritin <100 ng/mL or transferrin saturation (TSAT) <20%, found at hospital admission or within 15 days after the cardiac event.
Main reasons for not taking part
- Active cancer or ongoing bacteremia
- Heart failure with LVEF <40%
- Dialysis, or advanced liver or kidney failure
- Severe anemia (hemoglobin <10 g/dL)
- Known hypersensitivity to intravenous iron or its excipients
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previously diagnosed iron deficiency, identified and treated with intravenous or oral iron within the year prior to the event.
Other illness
- Patients with active cancer.
- Patients undergoing dialysis, or with advanced hepatic or renal failure.
- Patients with known hypersensitivity to intravenous iron or to any of the excipients in the product.
- Patients with known severe hypersensitivity to other parenteral iron products.
- Evidence of iron overload or disorders in iron utilization.
Lab values
- Patients with a prior diagnosis of heart failure (HF) with a left ventricular ejection fraction (LVEF) <40%, or who develop this condition during hospitalization or within 15 days following the acute coronary syndrome (ACS) event will be excluded.
- Patients with severe anemia (hemoglobin <10 g/dL) at the time of the event or within the subsequent 15 days.
Other
- Patients with ongoing bacteremia.
- Patients currently participating in other clinical trials involving investigational medicinal products.
- Patients who, in the opinion of the investigator, should not participate in the study due to difficulties in complying with procedures, restrictions, or requirements.
- Terminally ill patients as determined by the IDC-Pal score (Instrument for Diagnosing Complexity in Palliative Care).
Who the study is looking for
- Patients aged 65 years or older.
- Patients with a confirmed diagnosis of acute coronary syndrome (ACS) within a maximum of 15 days prior to inclusion.
- Patients with a confirmed diagnosis of iron deficiency at the time of hospital admission or within 15 days after the cardiac event, untreated, and defined by: - Serum ferritin <100 ng/mL, or - Transferrin saturation (TSAT) <20%, according to the European Society of Cardiology guidelines and the SEC_SEMI consensus.
- Ability to understand the study details and to provide written informed consent prior to any trial-related procedures.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Badajoz | Badajoz | Spain | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Universitario Clínico San Cecilio | Granada | Spain | Recruiting |
| Hospital Universitario De Leon | León | Spain | Recruiting |
| Hospital Clínico San Carlos | Madrid | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Recruiting |
| Hospital Universitario de Navarra | Pamplona | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Recruiting |
| Hospital Alvaro Cunqueiro | Vigo | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.