BIOmarker driven intensification of cardiovascular RISK factor management in patients with high risk for recurrent cardiovascular EVENTs The BIO-RISK-EVENT Study

Phase 3

Not yet recruiting

Conditions: Acute Myocardial Infarction

Registration Number: 2024-511950-35-00

Lead Sponsor: Medical University Of Graz

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 1758

Inclusion 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: 48 hours to 14 days after PCI)

BIO-RISK-EVENT score parameters available

Exclusion Criteria

Previous myocardial infarction (prior to the current event leading to enrolment)

Known drug or alcohol abuse or psychiatric disorder that, in the opinion of the investigator prevents participation from following the protocol

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

Women of child-bearing potential

Treatment with ciclosporin and strong CYP3A3 inhibitors

Current treatment with an SGLT2 inhibitor

Have family (first-degree-relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

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

Known history of retinopathy and/or macular oedema

Acute inflammatory disease (e.g. pneumonia, urinary tract infection, etc.)

Chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatoid arthritis, etc.)

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first event of a composite of cardiovascular outcomes encompassing - Cardiovascular death - Non-fatal myocardial infarction -Non-fatal stroke - Hospitalisation for urgent coronary revascularisation - Hospitalisation for heart failure		Time to first event of a composite of cardiovascular outcomes encompassing - Cardiovascular death - Non-fatal myocardial infarction -Non-fatal stroke - Hospitalisation for urgent coronary revascularisation - Hospitalisation for heart failure

Secondary Outcome Measures

Name	Time	Method
Time to first event for cardiovascular death		Time to first event for cardiovascular death
Time to all-cause mortality		Time to all-cause mortality
Time to first event for non-fatal myocardial infarction		Time to first event for non-fatal myocardial infarction
Time to first event for non-fatal stroke		Time to first event for non-fatal stroke
Time to first event for hospitalisation for urgent coronary revascularisation		Time to first event for hospitalisation for urgent coronary revascularisation
Time to first event for hospitalisation for heart failure		Time to first event for hospitalisation for heart failure
Time to first event of a composite of cardiovascular outcomes encompassing -Cardiovascular death -Non-fatal myocardial infarction -Non-fatal stroke		Time to first event of a composite of cardiovascular outcomes encompassing -Cardiovascular death -Non-fatal myocardial infarction -Non-fatal stroke
Time to first event of a composite of cardiovascular outcomes encompassing -Cardiovascular death -Hospitalisation for heart failure		Time to first event of a composite of cardiovascular outcomes encompassing -Cardiovascular death -Hospitalisation for heart failure
Time to first event for any urgent revascularisation procedure of a -Coronary artery -Carotid artery -Peripheral artery		Time to first event for any urgent revascularisation procedure of a -Coronary artery -Carotid artery -Peripheral artery
Time to first event for major adverse limb events		Time to first event for major adverse limb events

Trial Locations

Locations (29): Medical University Of Vienna
🇦🇹
Vienna, Austria
Konvent Der Barmherzigen Brueder
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Linz, Austria
Noe LGA Gesundheit Thermenregion GmbH
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Wiener Neustadt, Austria
Klinik Favoriten
🇦🇹
Vienna, Austria
Klinik Landstrabe
🇦🇹
Vienna, Austria
Ordensklinikum Linz GmbH
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Linz, Austria
Tirol Kliniken GmbH
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Innsbruck, Austria
Oberoesterreichische Gesundheitsholding GmbH
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Steyr, Austria
Noe LGA Gesundheit Region Mitte GmbH
🇦🇹
St. Poelten, Austria
Vivit Institute
🇦🇹
Feldkirch, Austria
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Medical University Of Vienna
🇦🇹Vienna, Austria
Jolanta Siller-Matula
Site contact
+4314040046140
jolanta.siller-matula@meduniwien.ac.at