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.
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