Myocardial Infarction, AcutePhase 4INFERRCTNCT05759078
Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
A Phase 4 study testing Ferinject and Sodium Chloride 0.9% Inj in people with Myocardial Infarction, Acute, run by Wroclaw Medical University at 43 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction, Acute
- What is being tested?
- Ferinject and Sodium Chloride 0.9% Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 43 sitesPoland
- Study dates
- 22 Sep 2022to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation;
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- 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
Who cannot join
- 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 <8 g/dL or >15,5 g/dL;
- Serum ferritin >400 ng/mL;
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- 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 basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia;
- 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 addiction.
Trial locations and contacts
43 sites in 1 country. Contact the study team or a site near you to ask about taking part.
43 sites in 1 country
Poland43 sites, 31 recruiting
- Recruiting
Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej
Bielsko-Biala, Silesian Voivodeship, 43-316
33 828 93 70
- Recruiting
Vitamed Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079
52 347 88 15
- Recruiting
Polsko-Amerykańskie Kliniki Serca Małopolskie Centrum Sercowo-Naczyniowe
Chrzanów, Lesser Poland Voivodeship, 32-500
32 758 69 00
- Recruiting
Uniwersyteckim Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship, 80-952
58 349 20 00
- Terminated
Szpital Specjalistyczny im. SS im. Henryka Klimontowicza w Gorlicach
Gorlice, Lesser Poland Voivodeship, 38-300
- Recruiting
Regionalny Szpital Specjalistyczny im. dr Wł. Biegańskiego w Grudziądzu
Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300
56 641 44 44
- Recruiting
Centrum Opieki Medycznej w Jarosławiu
Jarosław, Podkarpackie Voivodeship, 37-500
16 621 54 21
- Recruiting
Polsko-Amerykańskie Kliniki Serca Centrum Sercowo-Naczyniowe w Kędzierzynie Koźlu
Kędzierzyn-Koźle, Opole Voivodeship, 47-200
77 472 25 65
- Recruiting
Zespół Opieki Zdrowotnej w Kłodzku
Kłodzko, Lower Silesian Voivodeship, 57-300
74 865 12 00
- Recruiting
Centrum Kardiologii w Kluczborku Scanmed S.A.
Kluczbork, Opole Voivodeship, 46-200
77 410 82 18
- Recruiting
Szpital Specjalistyczny im. J. Dietla w Krakowie
Krakow, Lesser Poland Voivodeship, 31-121
12 68 76 200
- Recruiting
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow
- Terminated
4Cardia Sp. z o.o.
Kraśnik, Lublin Voivodeship, 23-204
- Terminated
Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii w Krośnie
Krosno, Podkarpackie Voivodeship, 38-400
- Recruiting
Wojewódzki Szpital Specjalistyczny w Legnicy
Legnica
- Recruiting
Nzoz Salusmed
Lodz, Łódź Voivodeship, 91-002
42 671 34 34
- Recruiting
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, Łódź Voivodeship, 92-213
42 201 42 40
- Terminated
1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie
Lublin, Lublin Voivodeship, 20-049
- Terminated
Ośrodek Kardiologii Inwazyjnej IKARDIA Sp. z o.o.
Nałęczów, Lublin Voivodeship, 24-140
- Terminated
Podhalański Szpital Specjalistyczny im. Jana Pawła II w Nowym Targu
Nowy Targ, Lesser Poland Voivodeship, 34-400
- Recruiting
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opole Voivodeship, 45-401
77 452 07 45
- Recruiting
Medicome Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, 32-600
48 505 121 703
- Recruiting
Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej im. dr Wojciecha Oczko w Przasnyszu
Przasnysz
- Recruiting
Wojewódzki Szpital im. Św. Ojca Pio
Przemyśl
- Terminated
Szpital Specjalistyczny Ducha Świętego w Sandomierzu
Sandomierz
- Terminated
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
Słupsk, Pomeranian Voivodeship, 76-200
- Recruiting
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie
Szczecin, West Pomeranian Voivodeship, 70-111
91 466 10 00
- Recruiting
Polsko-Amerykańskie Kliniki Serca Centrum Kardiologiczno-Angiologiczne w Sztumie
Sztum, Pomeranian Voivodeship, 82-400
55 625 92 20
- Terminated
Szpital Wojewódzki im. św. Łukasza SP ZOZ w Tarnowie
Tarnów, Lesser Poland Voivodeship, 33-100
- Recruiting
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
56 679 31 00
- Recruiting
Polsko-Amerykańskie Kliniki Serca, X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach
Tychy, Silesian Voivodeship, 43-100
32 758 67 00
- Terminated
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Masovian Voivodeship, 02-507
- Recruiting
Mazowiecki Szpital Bródnowski Sp. z o.o.
Warsaw, Masovian Voivodeship, 03-242
22 326 52 26
- Recruiting
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, 04-349
26 181 76 66
- Recruiting
Medicover Sp z o.o.
Warsaw
- Recruiting
Uniwersytecki Szpital kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, 50-556
71 736 42 76
- Terminated
4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wroclaw, Lower Silesian Voivodeship, 50-981
- Recruiting
Dolnośląski Szpital Specjalistyczny im. T. Marciniaka - Centrum Medycyny Ratunkowej
Wroclaw, Lower Silesian Voivodeship, 54-049
71 306 44 19
- Recruiting
Szpital Specjalistyczny w Zabrzu Sp. z o.o.
Zabrze
- Recruiting
Śląskie Centrum Chorób Serca w Zabrzu
Zabrze
- Terminated
Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii Med-Pro
Zgierz, Łódź Voivodeship, 95-100
- Recruiting
Wielospecjalistyczny Szpital SP ZOZ w Zgorzelcu
Zgorzelec, Lower Silesian Voivodeship, 59-900
75 772 29 00
- Recruiting
Szpital Uniwersytecki imienia Karola Marcinkowskiego w Zielonej Górze Sp. z o. o.
Zielona Góra, Lubusz Voivodeship, 65-046
68 329 62 00
About this study
Official title: Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion SUBTITLE Prevention of Cardiovascular Death, Heart Failure Events and Deterioration in Quality of Life With INtravenous FERRic Carboxymaltose in Iron Deficient Patients With Recent Myocardial Infarction
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:
Read more
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).
- Conditions
- Myocardial Infarction, Acute
- Being tested
- Ferinject, Sodium Chloride 0.9% Inj
- Keywords
- Myocardial infarction, acute, iron deficiency, Infusion, ferric carboxymaltose
- Medical subject headings
- Myocardial Infarction, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerinjectDrug
The first dose of either FCM will be administered during the first visit on the day of randomisation (V1). Then, the participants will be reassessed at 4, 8, 12, 18, 24 and 30 months (visits V2, V3, V4, V5, V6, V7). If safety criteria are not fulfilled, a patient in the active study arm will receive i.v. NaCl 0.9% during the particular visit.
Sodium Chloride 0.9% InjDrug
The first dose of placebo will be administered during the first visit on the day of randomisation (V1). Then, the participants will be reassessed at 4, 8, 12, 18, 24 and 30 months (visits V2, V3, V4, V5, V6, V7).
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | an i.v. 15-minute infusion of 20 mL Ferinject (containing 1000 mg of FCM) diluted in 50 mL of NaCl 0.9% Receives: Drug: Ferinject |
| Placebo | Placebo comparator | 70 mL of i.v. NaCl 0.9% infusion Receives: Drug: Sodium Chloride 0.9% Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to all-cause death assessed up to maximum 36-months follow-up;
Defined as: (with an implementation of a win ratio approach in a hierarchical descending order):
- Time to all-cause death assessed up to maximum 36-months follow-up;
- Number of HFE assessed up to maximum 36-months follow-up;
- Time to first HFE assessed up to maximum 36-months follow-up;
- Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve;
- Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve.
- 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).
Measured: up to 36 months
Number of HFE assessed up to maximum 36-months follow-up
Number of HFE
Measured: up to 36 months
Time to first HFE assessed up to maximum 36-months follow-up
Time to first HFE
Measured: up to 36 months
Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve
Changes in serum NT-proBNP
Measured: up to 36 months
Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve
Changes in quality of life
Measured: up to 36 months
Secondary outcomes (5)
First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up (time-to-event model)
First unplanned HF hospitalisation or unplanned visit at emergency
Measured: up to 36 months
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up (recurrent event model);
All unplanned HF hospitalisations and unplanned visit at emergency
Measured: up to 36 months
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up (recurrent event model)
All unplanned HF hospitalisations and unplanned visit at emergency department
Measured: up to 36 months
All unplanned HF hospitalisations during the follow-up (recurrent event model);
All unplanned HF hospitalisations
Measured: up to 36 months
CV death during the follow-up
CV death
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start22 Sep 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Ponikowski, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759078
- Sponsor's protocol ID
- 2019/ABM/01/00081
- Acronym
- INFERRCT
- Status last verified
- Jul 2025
- First submitted
- 16 Jan 2023
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion SUBTITLE Prevention of Cardiovascular Death, Heart Failure Events and Deterioration in Quality of Life With INtravenous FERRic Carboxymaltose in Iron Deficient Patients With Recent Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05759078
- Acronym / sponsor ID
- INFERRCT / 2019/ABM/01/00081
- Conditions
- Myocardial Infarction, Acute
- Keywords
- Myocardial infarction, acute, iron deficiency, Infusion, ferric carboxymaltose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Ferinjectan i.v. 15-minute infusion of 20 mL Ferinject (containing 1000 mg of FCM) diluted in 50 mL of NaCl 0.9% |
| Placebo | Placebo comparator | Drug: Sodium Chloride 0.9% Inj70 mL of i.v. NaCl 0.9% infusion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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):
- Written informed consent
Key exclusion criteria (14 listed)
- 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 <8 g/dL or >15,5 g/dL;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerinjectThe first dose of either FCM will be administered during the first visit on the day of randomisation (V1). Then, the participants will be reassessed at 4, 8, 12, 18, 24 and 30 months (visits V2, V3, V4, V5, V6, V7). If safety criteria are not fulfilled, a patient in the active study arm will receive i.v. NaCl 0.9% during the particular visit. | Drug | Active |
| Sodium Chloride 0.9% InjThe first dose of placebo will be administered during the first visit on the day of randomisation (V1). Then, the participants will be reassessed at 4, 8, 12, 18, 24 and 30 months (visits V2, V3, V4, V5, V6, V7). | Drug | Placebo |
Primary outcome
Time to all-cause death assessed up to maximum 36-months follow-up;
Time frame: up to 36 months
Defined as: (with an implementation of a win ratio approach in a hierarchical descending order): 1. Time to all-cause death assessed up to maximum 36-months follow-up; 2. Number of HFE assessed up to maximum 36-months follow-up; 3. Time to first HFE assessed up to maximum 36-months follow-up; 4. Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve; 5. Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve. * 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).
Number of HFE assessed up to maximum 36-months follow-up
Time frame: up to 36 months
Number of HFE
Time to first HFE assessed up to maximum 36-months follow-up
Time frame: up to 36 months
Time to first HFE
Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve
Time frame: up to 36 months
Changes in serum NT-proBNP
Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve
Time frame: up to 36 months
Changes in quality of life
5 secondary outcomes
First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up (time-to-event model)
Time frame: up to 36 months
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up (recurrent event model);
Time frame: up to 36 months
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up (recurrent event model)
Time frame: up to 36 months
All unplanned HF hospitalisations during the follow-up (recurrent event model);
Time frame: up to 36 months
CV death during the follow-up
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piotr Ponikowski principal investigator
Wroclaw Medical University
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferinject and Sodium Chloride 0.9% Inj in people with Myocardial Infarction, Acute, run by Wroclaw Medical University at 43 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Duda-Sikuła (717840696 ext. 0048, marta.duda-sikula@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to all-cause death assessed up to maximum 36-months follow-up; (time frame: up to 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.