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NCT07892976Not yet recruiting

The CORE Platform Trial

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

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
15000 (estimated)
First submitted
19 Oct 2026
Start date
Jan 2027
Primary completion date
Jan 2044
Lead sponsor
Copenhagen Trial Unit, Center for Clinical Intervention Research
NCT number
NCT07892976

What you commit to

  • Study type: Interventional
  • Planned participants: 15000
  • From Jan 2027 to the primary completion date, Jan 2044
  • 3 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Chronic kidney disease with estimated glomerular filtration rate \< 20 mL/min/kg
  • ST-elevation myocardial infarction (STEMI) within 1 month

Other

  • Pregnancy
  • Indication for acute revascularisation
  • Other separate exclusion criteria may be defined for each randomised comparison in the platform.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status
Copenhagen University Hospital, Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkUnknown status
UMC Utrecht
Coordinator of this site? Confirm its status
UtrechtNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.