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New treatment option for Myocardial Infarction, Acute
Official title Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
ClinicalTrials.gov ID: NCT05759078
What this study is testing
What is Ferinject?
Ferinject is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for myocardial infarction, acute.
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
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Age ≥18 years;
- Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation
- Presence of iron deficiency (ID) defined as transferrin saturation TSAT\<20% assessed within up to 4 weeks (28 days) before randomisation;
- Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present):
- LVEF ≤50%;
You likely can't join if
- Subject temperature \>38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation;
- Severe, symptomatic valve disorder;
- Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation).
- Body weight \<50 kg;
- Haemoglobin \ 15,5 g/dL;
- Serum ferritin \>400 ng/mL;
See the full eligibility criteria
- Age ≥18 years;
- Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation
- Presence of iron deficiency (ID) defined as transferrin saturation TSAT\<20% assessed within up to 4 weeks (28 days) before randomisation;
- Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present):
- LVEF ≤50%;
- NT-proBNP ≥400 pg/mL for people in sinus rhythm and NT-proBNP ≥800 pg/mL for people with atrial fibrillation;
- Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use;
- Diagnosis of diabetes mellitus (also de novo diagnosis);
- Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis);
- Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI);
- Not complete revascularisation or/and no reperfusion (during an index AMI);
- History of AMI (despite an index AMI);
- eGFR \<60 mL/min/1.73m2; 1. Age ≥70 years.
- Written informed consent
- Subject temperature \>38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation;
- Severe, symptomatic valve disorder;
- Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation).
- Body weight \<50 kg;
- Haemoglobin \ 15,5 g/dL;
- Serum ferritin \>400 ng/mL;
- Active gastroenteral bleeding;
- Known hypersensitivity to any of the administered preparations;
- Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation;
- 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...
- Documented liver diseases;
- 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;
- Pregnancy or lactation;
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
- Torun, Kuyavian-Pomeranian Voivodeship, Poland
- Chrzanów, Lesser Poland Voivodeship, Poland
- Gorlice, Lesser Poland Voivodeship, Poland
- Krakow, Lesser Poland Voivodeship, Poland
- Nowy Targ, Lesser Poland Voivodeship, Poland
- Oświęcim, Lesser Poland Voivodeship, Poland
- Tarnów, Lesser Poland Voivodeship, Poland
- Kłodzko, Lower Silesian Voivodeship, Poland
- Wroclaw, Lower Silesian Voivodeship, Poland
- Zgorzelec, Lower Silesian Voivodeship, Poland
- Kraśnik, Lublin Voivodeship, Poland
- Lublin, Lublin Voivodeship, Poland
- Nałęczów, Lublin Voivodeship, Poland
- Zielona Góra, Lubusz Voivodeship, Poland
- Warsaw, Masovian Voivodeship, Poland
- Kędzierzyn-Koźle, Opole Voivodeship, Poland
- Kluczbork, Opole Voivodeship, Poland
- Opole, Opole Voivodeship, Poland
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland; Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland; Torun, Kuyavian-Pomeranian Voivodeship, Poland; Chrzanów, Lesser Poland Voivodeship, Poland; Gorlice, Lesser Poland Voivodeship, Poland; Krakow, Lesser Poland Voivodeship, Poland and 31 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.