WROCLAW MEDICAL UNIVERSITY
INFERRCT clinical trial
PHASE IV
long-term post-approval
medicinal product surveillance
NON-COMMERCIAL
conducted to expand knowledge
and develop clinical practice
MULTICENTRE
on the basis of a single protocol in multiple research centres nationwide in Poland
News
What stage is the study at?
The INFERRCT study is the largest multicentre non-commercial trial conducted by the Wroclaw Medical University and funded by the Medical Research Agency.
The first patient was enrolled on September 22, 2022 at the Jan Mikulicz-Radecki University Clinical Hospital in Wroclaw.
Currently, more than 30 centres from all over Poland are contracted. We have an impressive rate of 50 centres launched ahead of us to achieve, so without slowing down, we are in talks with other centres and clinics . Therefor, we encourage all specialist physicians interested in joining the Investigators and executing the INFERRCT study at your centres to contact us by filling out Contact Form.
What does patient participation in the study look like?
Participation in the study lasts 12 months. The process of recruiting a patient for the study begins while the patient is still in the hospital or in the outpatient setting up to 4 weeks after an acute myocardial infarction. After verification of the patient’s diagnostic test results, including confirmation of the presence of concomitant iron deficiency in the blood along with the patient’s informed consent to participate in the clinical trial, the patient is qualified as a clinical trial participant.
The next step is randomization, which means that the patient is assigned to one of the groups – receiving the investigational medicinal product (study group) or placebo (control group). Assignment to the appropriate group is randomized using a computer system, the same day the patient receives the first dose of intravenous iron preparation or placebo.
The patient enrolled in the study, according to the protocol, will have a total of four visits. After the visit at which he was assigned to a particular group, he will be required to attend subsequent visits to the center after 4, 8 and 12 months. During two of these visits, after medical and diagnostic tests, including selected laboratory parameters for assessing iron deficiency in the blood, the patient will be given an intravenous drug product or a placebo. The last visit, concluding participation in the study, includes diagnostics of the patient’s health status (medical and laboratory tests).
During each visit, the participant also completes a quality of life questionnaire.
