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Comparing heart bypass surgery approaches in adults with coronary artery disease

Tests MIDCAB and CABG procedures in adults with coronary artery disease needing revascularization.

Plain-language title generated from the registry record
Registry title: The CORE Platform Trial

Key facts

Where
Leuven, BelgiumSee the site

Where in Belgium

  • UZ LeuvenLeuven, BelgiumNo longer taking part

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Trial details

Who runs it
Copenhagen Trial Unit, Center for Clinical Intervention Research
Trial code
NCT07892976
Record updated
27 October 2026
Original description
Background: The leading cause of death worldwide is cardiovascular disease, with an estimated 19.8 million deaths per year. Coronary artery disease is a type of cardiovascular disease that can be treated with revascularisation interventions like coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) and hybrid revascularisation. The COronary Revascularisation (CORE) Platform Trial is a multicentre, investigator-initiated, platform trial designed to evaluate several procedural and medical interventions for treatment of patients with coronary artery disease referred for coronary artery revascularisation.Read full original descriptionShow less

The COronary REvascularisation Platform Trial: Study Master Protocol for a Platform Trial

Background: The leading cause of death worldwide is cardiovascular disease, with an estimated 19.8 million deaths per year. Coronary artery disease is a type of cardiovascular disease that can be treated with revascularisation interventions like coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) and hybrid revascularisation. The COronary Revascularisation (CORE) Platform Trial is a multicentre, investigator-initiated, platform trial designed to evaluate several procedural and medical interventions for treatment of patients with coronary artery disease referred for coronary artery revascularisation.

Methods: This Master Protocol describes the overarching design, organisation, and methodology of the CORE Platform Trial. The target population will be adults with coronary artery disease referred for coronary artery revascularisation. The platform will allow interventions to be assessed in parallel or sequentially across separate domains, each with predefined sample sizes, outcomes, and statistical analysis plans. The CORE Platform Trial is guided by three overarching principles: to promote and establish international collaboration; to conduct pragmatic trials that generate findings applicable to routine clinical practice while avoiding compromise to methodological rigour; and to avoid unnecessary complexity in methodology and statistical analyses. The HYCORE1 trial serves as the initial domain within the platform, with future domains including colchicine; sodium-glucose co-transporter 2 inhibitor; and hybrid versus PCI revascularisation. Randomisation will be web-based with allocation concealment, stratification by site and domain, and blinding where feasible.

Discussion: The CORE Platform Trial provides a collaborative, pragmatic, and methodologically rigorous framework for evaluating interventions in patients with coronary artery disease referred for coronary artery revascularisation. By using shared infrastructure and predefined domain-specific protocols, the platform aims to improve efficiency, reduce research waste, and strengthen the evidence base for coronary artery disease care.

Inclusion: Written informed consent; Adults (greater or equal to 18 years of age); Diagnosed with coronary artery disease; Referred for coronary artery disease of any type; Other separate inclusion criteria may be defined for each randomised comparison in the platform.

Exclusion: Chronic kidney disease with estimated glomerular filtration rate < 20 mL/min/kg; ST-elevation myocardial infarction (STEMI) within 1 month; Pregnancy; Indication for acute revascularisation; Other separate exclusion criteria may be defined for each randomised comparison in the platform.

ClinicalTrials.gov NCT07892976