Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion

Recruiting Phase 4 Interventional Study
Myocardial Infarction, Acute
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 90
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
1,000 (estimated)
Sponsor
Wroclaw Medical University · Other
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About This Trial
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 tr…
Trial Locations
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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…
Contacts

Marta Duda-Sikuła

717840696

marta.duda-sikula@umw.edu.pl

CONTACT

Julia Raińczuk

717840697

julia.rainczuk@umw.edu.pl

CONTACT