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New treatment option for Acute Coronary Syndromes (ACS)
Official title Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome
ClinicalTrials.gov ID: NCT07476859
What this study is testing
What is Ferric Carboxymaltose Injection [Ferinject]?
Ferric Carboxymaltose Injection [Ferinject] is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute coronary syndromes (acs).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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%.
You likely can't join if
- Active malignancy.
- End-stage or terminal illness as determined by the IDC-Pal score.
- Known heart failure with left ventricular ejection fraction (LVEF) \< 40% prior to enrollment, or development of LVEF \< 40% during hospitalization...
- Chronic dialysis or advanced renal or hepatic failure.
- Severe anemia (hemoglobin \< 10 g/dL) at the time of ACS or within 15 days after the event.
- Prior treatment with intravenous or oral iron within 12 months before the index ACS.
See the full eligibility criteria
- 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.
- Active malignancy.
- End-stage or terminal illness as determined by the IDC-Pal score.
- 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.
- Chronic dialysis or advanced renal or hepatic failure.
- Severe anemia (hemoglobin \< 10 g/dL) at the time of ACS or within 15 days after the event.
- Prior treatment with intravenous or oral iron within 12 months before the index ACS.
- Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation.
- Evidence of iron overload or disorders of iron metabolism.
- Ongoing bacteremia or active systemic infection.
- Participation in another treatment clinical trial involving an investigational medicinal product.
- Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity.
The study team makes the final eligibility decision.
Where it's taking place
- El Palmar, Murcia, Spain
- Vigo, Pontevedra, Spain
- Badajoz, Spain
- Barcelona, Spain
- Granada, Spain
- León, Spain
- Madrid, Spain
- Pamplona, Spain
- Valencia, Spain
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include El Palmar, Murcia, Spain; Vigo, Pontevedra, Spain; Badajoz, Spain; Barcelona, Spain; Granada, Spain; León, Spain and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.