An interventional study of MIDCAB procedure and CABG procedure in Coronary Revascularization and Coronary Artery Disease, sponsored by Copenhagen Trial Unit, Center for Clinical Intervention Research. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Copenhagen Trial Unit, Center for Clinical Intervention Research · Not applicable, Interventional, and Treatment
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 (CABG and PCI). 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 rigor; 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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 15,000 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Copenhagen Trial Unit, Center for Clinical Intervention Research is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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The CORE Platform Trial will include adults (greater or equal to 18 years of age) with coronary artery disease who are referred for coronary artery revascularization of any type.
Separate inclusion criteria will be defined for each randomised comparison in the platform.
Exclusion Criteria:
Separate exclusion criteria will be defined for each randomised comparison in the platform.
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.
Procedure: MIDCAB procedure
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.
Procedure: CABG 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.
Also known as: Hybrid revascularisation
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.
A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization (the primary outcomes defined for the first randomised comparison in the CORE Platform Trial)
Outcomes will be specified separately for each domain in the corresponding domain-specific protocols. The primary outcome and most secondary outcomes within each domain will be patient-important, clinical, hard binary outcomes (e.g., mortality). Symptom-based outcomes and health-related quality of life measures may also be included where relevant.
Time frame: 12 months after randomization
Angina symptoms (an example of a secondary outcome used in the first randomised comparison in the CORE Platform Trial).
Angina symptoms measured using Seattle Angina Questionnaire Range \[0-100\] for each domain, a higher score indicates a better health, fewer symptions, higher functions, higher quality of life.
Time frame: 12 months after randomization
Health-related quality of life (an example of a secondary outcome used in the first randomised comparison in the CORE Platform Trial).
Health related quality of life using EQ-5D Range \[0-100\], a higher score indicates a better health.
Time frame: 12 months after randomization
Hospital free days (an example of a secondary outcome used in the first randomised comparison in the CORE Platform Trial).
Hospital free days
Time frame: 90 days after randomization
Plan to share: Yes — We plan to make all data publicly available in peer-review papers, after the trial has been finalized.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: At the end of the trial
Access criteria: In peer-review papers
Start is estimated for Jan 2027; primary completion for Jan 2044, 204 months later.
Of 856 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 204 months is above that.
Counting every sponsor, half of 1,033 studies reached it within 29 months; a quarter within 14 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Copenhagen Trial Unit, Center for Clinical Intervention Research