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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Graz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

12 Jun 2025 → ongoing

Decision date (initial)

2025-05-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

European Union

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

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.

Secondary objectives 1

1. Secondary objectives are to evaluate the efficacy (in terms of single components of the primary composite endpoint and other cardiovascular endpoints) of intensified residual risk management versus standard guideline treatment

Conditions and MedDRA coding

Acute Myocardial Infarction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Individuals > 18 years of age
2. Written consent of the participant after being informed
3. Percutaneous coronary intervention (PCI) procedure for acute myocardial infarction (inclusion window: 48 hours to 14 days after PCI)
4. BIO-RISK-EVENT score parameters available

Exclusion criteria 22

1. Previous myocardial infarction (prior to the current event leading to enrolment)
2. Current treatment with an SGLT2 inhibitor
3. Current treatment with colchicine
4. Current treatment with icosapent ethyl
5. Known allergy to any of the medications being used for intensified treatment or their constituents, or to medications with a similar chemical structure
6. Active known malignancies within the last year, except intraepithelial neoplasm of the prostate, gastrointestinal tract and basal cell carcinoma
7. Known history of retinopathy and/or macular oedema
8. Acute inflammatory disease (e.g. pneumonia, urinary tract infection, etc.)
9. Chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatoid arthritis, etc.)
10. Known drug or alcohol abuse or psychiatric disorder that, in the opinion of the investigator prevents participation from following the protocol
11. Haemodynamic instability as defined by intravenous administration of catecholamines, calcium sensitisers or phosphodiesterase inhibitors
12. New York Heart Failure (NYHA) Functional Classification Class IV heart failure at baseline
13. Participation in another clinical trial that may affect the results of this study
14. Type 1 diabetes mellitus
15. eGFR <45 mL/min/1.73 m2
16. Liver cirrhosis Childs B or C or other known liver disease preventing the study candidate to participate according to the judgment of the investigator
17. Women who are pregnant or breast-feeding
18. Women of child-bearing potential
19. Treatment with ciclosporin and strong CYP3A3 inhibitors
20. Have family (first-degree-relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
21. Have had a transplanted organ or awaiting an organ transplant
22. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 10

1. Time to first event for cardiovascular death
2. Time to all-cause mortality
3. Time to first event for non-fatal myocardial infarction
4. Time to first event for non-fatal stroke
5. Time to first event for hospitalisation for urgent coronary revascularisation
6. Time to first event for hospitalisation for heart failure
7. Time to first event of a composite of cardiovascular outcomes encompassing -Cardiovascular death -Non-fatal myocardial infarction -Non-fatal stroke
8. Time to first event of a composite of cardiovascular outcomes encompassing -Cardiovascular death -Hospitalisation for heart failure
9. Time to first event for any urgent revascularisation procedure of a -Coronary artery -Carotid artery -Peripheral artery
10. Time to first event for major adverse limb events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Graz

Sponsor organisation

Medical University Of Graz

Address

Neue Stiftingtalstrasse 6

City

Graz

Postcode

8010

Country

Austria

Scientific contact point

Organisation

Medical University Of Graz

Contact name

Prof. Harald Sourij

Public contact point

Organisation

Medical University Of Graz

Contact name

Trials Unit for Interdisciplinary Metabolic Medicine

Locations

3 EU/EEA countries · 35 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 26 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications