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BIOmarker driven intensification of cardiovascular RISK factor management in patients with high risk for recurrent cardiovascular EVENTs The BIO-RISK-EVENT Study
EU CTIS ID: 2024-511950-35-00
What this study is testing
The primary objective of the randomized controlled trial is to evaluate the efficacy (in terms of a composite effect) of intensified residual risk management versus standard guideline treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Individuals > 18 years of age
- Written consent of the participant after being informed
- Percutaneous coronary intervention (PCI) procedure for acute myocardial infarction (inclusion window: 24 hours to 8 days after PCI)
- BIO-RISK-EVENT score parameters available
You likely can't join if
- Previous myocardial infarction (prior to the current event leading to enrolment)
- Women of child-bearing potential
- Treatment with ciclosporin and strong CYP3A3 inhibitors
- Treatment with an SGLT2 inhibitor initiated prior to PCI
- Have had a transplanted organ or awaiting an organ transplant
- Men whose partners are capable of becoming pregnant may only participate in the clinical study if they commit to using a reliable method of contraception throughout the study duration and for at least 6 months after the end of the trial medication
See the full eligibility criteria
- Individuals > 18 years of age
- Written consent of the participant after being informed
- Percutaneous coronary intervention (PCI) procedure for acute myocardial infarction (inclusion window: 24 hours to 8 days after PCI)
- BIO-RISK-EVENT score parameters available
- Previous myocardial infarction (prior to the current event leading to enrolment)
- Women of child-bearing potential
- Treatment with ciclosporin and strong CYP3A3 inhibitors
- Treatment with an SGLT2 inhibitor initiated prior to PCI
- Have had a transplanted organ or awaiting an organ transplant
- Men whose partners are capable of becoming pregnant may only participate in the clinical study if they commit to using a reliable method of contraception throughout the study duration and for at least 6 months after the end of the trial medication
- Current treatment with colchicine
- Current treatment with icosapent ethyl
- Known allergy to any of the medications being used for intensified treatment or their constituents, or to medications with a similar chemical structure
- Active known malignancies within the last year, except intraepithelial neoplasm of the prostate, gastrointestinal tract and basal cell carcinoma
- Acute inflammatory disease (e.g. pneumonia, urinary tract infection, etc.)
- Known drug or alcohol abuse or psychiatric disorder that, in the opinion of the investigator prevents participation from following the protocol
- Chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatoid arthritis, etc.)
- Haemodynamic instability as defined by intravenous administration of catecholamines, calcium sensitisers or phosphodiesterase inhibitors
- New York Heart Failure (NYHA) Functional Classification Class IV heart failure at baseline
- Participation in another clinical trial that may affect the results of this study
- Type 1 diabetes mellitus
- eGFR <45 mL/min/1.73 m2
- Liver cirrhosis Childs B or C or other known liver disease preventing the study candidate to participate according to the judgment of the investigator
- Women who are pregnant or breast-feeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.