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The CORE Platform Trial
Sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
Summary
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.
Official title: The COronary REvascularisation Platform Trial: Study Master Protocol for a Platform Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15000
Start Date
2027-01-01
Completion Date
2044-01
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
MIDCAB procedure
The MIDCAB procedure aims to provide a less invasive approach to revascularisation than CABG, while providing greater treatment flexibility than PCI alone. MIDCAB involves grafting the left anterior descending artery (LAD) through a small anterior thoracotomy incision, eliminating the need for extracorporeal circulation (heart-lung machine) and sternotomy. This approach ensures vital revascularisation with reduced surgical trauma. Hybrid coronary revascularisation (HCR) combines the advantages of invasive cardiology, including stents, and cardiac surgery. This procedure involves minimally invasive grafting of the left internal mammary artery (LIMA) to the LAD, combined with PCI of all significant non-LAD stenoses.
CABG procedure
Coronary artery bypass grafting (CABG) is a common surgical procedure with a full sternotomy and bypass grafting. CABG is considered the gold standard for treating complex multivessel coronary artery disease.
Locations (3)
UZ Leuven
Leuven, Belgium
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Capital Region, Denmark
UMC Utrecht
Utrecht, Netherlands