Evaluation of carboxymaltose treatment in patients with myocardial infarction associated with iron deficiency

Phase 1

• Conditions: Recent myocardial infarction associated with iron deficient; MedDRA version: 20.0Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-005740-27-PL
• Lead Sponsor: niwersytet Medyczny im. Piastów Slaskich we Wroclawiu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-11
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1)Age =18 years;
2)Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks before radomisation;
3)Presence of iron deficiency (ID) defined as transferrin saturation TSAT<20% and/or serum ferritin <100 ng/mL assessed up to 4 weeks before radomisation;
4)Presence of =3 factors (confirmed within up to 4 weeks before radomisation)
(note: at least one of a-c must be present):
(a)LVEF =50%;
(b)NT-proBNP =400 pg/mL for subjects in sinus rhythm and NT-proBNP =800 pg/mL for subjects with atrial fibrillation;
(c)Clinical features of congestion/volume overload (including Killip class II or more) requiring IV i.v. loop diuretic use;
(d)Diagnosis of diabetes mellitus (also de novo diagnosis);
(e)Diagnosis of atrial fibrillation (any time in the past or de novo diagnosis);
(f)Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI);
(g)Not complete revascularisation or/and no reperfusion (during an index AMI);
(h)History of AMI (despite an index AMI);
(i)eGFR <60 mL/min/1.73m2;
(j)Age =70 years.
5)Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1200

Exclusion Criteria

1)Subject temperature>38 ? C or any infection requiring antibiotic therapy within 48 hours prior to randomisation.
2)Severe, symptomatic valvular disorder.
3)Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation).
4)Body weight <50 kg.
5)Hemoglobin<8 g/dL or>15g/dL.
6)Serum ferritin>400 ng/mL.
7)TSAT>40%.
8)Active gastroenteral bleeding.
9)Hypersensitivity to any of the administered preparations.
10)Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation.
11)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.
12)Documented liver diseases.
13)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.
14)Pregnancy or lactation.
15)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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified