NCT05759078 Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
| NCT ID | NCT05759078 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Wroclaw Medical University |
| Condition | Myocardial Infarction, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-09-22 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 1,000 participants in total. It began in 2022-09-22 with a primary completion date of 2026-12-31.
⚠ 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
Non-commercial, multicentre, randomised, double-blind, parallel group, placebo-controlled clinical trial. Eligible patients were randomly assigned (1:1) using a secure, central, interactive, web-based response system, to intervention FCM or placebo arm. Time of observation: minimum of 8 months up to a maximum of 36 months. Primary Study Objective: Primary: Evaluation of the effect of i.v. FCM treatment compared with placebo on the risk of death, the risk of heart failure events (HFE\*) (number of events and time to first event), NTproBNP concentration and the change in quality of life (QoL) assessed using EQ-5D during the follow-up up to 36-months in patients with recent AMI and ID (with an implementation of a win ratio approach in a hierarchical descending order). \*HFE: unplanned hospitalization for HF (including unplanned visit at emergency department due to HF), ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms).
Eligibility Criteria
Inclusion criteria: 1. Age ≥18 years; 2. Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation 3. Presence of iron deficiency (ID) defined as transferrin saturation TSAT\<20% assessed within up to 4 weeks (28 days) before randomisation; 4. Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present): 1. LVEF ≤50%; 2. NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation; 3. Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use; 4. Diagnosis of diabetes mellitus (also de novo diagnosis); 5. Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis); 6. Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI); 7. Not complete revascularisation or/and no reperfusion (during an index AMI); 8. History of AMI (despite an index AMI); 9. eGFR \<60 mL/min/1.73m2; 1. Age ≥70 years. 5. Written informed consent Exclusion criteria: 1. Subject temperature \>38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation; 2. Severe, symptomatic valve disorder; 3. Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation). 4. Body weight \<50 kg; 5. Haemoglobin \<8 g/dL or \>15,5 g/dL; 6. Serum ferritin \>400 ng/mL; 7. Active gastroenteral bleeding; 8. Known hypersensitivity to any of the administered preparations; 9. Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation; 10. Subject has known active malignancy of any organ system, i.e., clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia; 11. Documented liver diseases; 12. Participation in a device or drug trial within 3 months prior to randomisation or 5 half-lives, whichever period is longer, prior to the screening visit; 13. Pregnancy or lactation; 14. Any situation that may prevent the test from being performed in accordance with the protocol, or the consent of the investigator to be given in writing, including alcohol, drugs or any other substance overuse or addiction.
Contact & Investigator
Piotr Ponikowski
PRINCIPAL INVESTIGATOR
Wroclaw Medical University
Frequently Asked Questions
Who can join the NCT05759078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Myocardial Infarction, Acute. 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 NCT05759078 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 NCT05759078 currently recruiting?
Yes, NCT05759078 is actively recruiting participants. Contact the research team at marta.duda-sikula@umw.edu.pl for enrollment information.
Where is the NCT05759078 trial being conducted?
This trial is being conducted at Bydgoszcz, Poland, Grudziądz, Poland, Torun, Poland, Chrzanów, Poland and 11 additional locations.
Who is sponsoring the NCT05759078 clinical trial?
NCT05759078 is sponsored by Wroclaw Medical University. The principal investigator is Piotr Ponikowski at Wroclaw Medical University. The trial plans to enroll 1,000 participants.