The CORE Platform Trial

NCT07892976 | Not Yet Recruiting DMC

• 1 other identifier: CORE-PLATFORM (CORE-DP-593)
• Study Type: interventional
• Target: 15,000
• Locations: 3 countries
• Sites: 3

Brief 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 (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.

Conditions

Coronary Revascularization; Coronary Artery Disease

Keywords

Platform trial; Coronary revascularization; Master protocol

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after randomization

Secondary Outcomes (3)

• Angina symptoms (an example of a secondary outcome used in the first randomised comparison in the CORE Platform Trial).

  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).

  12 months after randomization

• Hospital free days (an example of a secondary outcome used in the first randomised comparison in the CORE Platform Trial).

  90 days after randomization

Study Arms (2)

Minimally invasive direct coronary artery bypass (MIDCAB) procedure

EXPERIMENTAL

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

Conventional coronary artery bypass grafting (CABG) procedure

ACTIVE COMPARATOR

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

Interventions

MIDCAB procedure 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

Minimally invasive direct coronary artery bypass (MIDCAB) procedure

CABG procedure 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.

Conventional coronary artery bypass grafting (CABG) procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen Trial Unit, Center for Clinical Intervention Research: lead
• Copenhagen University Hospital, Rigshospitalet: collaborator
• UMC Utrecht: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (3)

UZ Leuven

Leuven, Belgium

Location

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (5)

• Perner A, Kjaer MN, Thorsen-Meyer HC, Kaas-Hansen BS, Munch MW, Collet MO, Bruun CR, Jensen AK, Lange T, Albertsen T, Pedersen CD, Poulsen LM, Mathiesen O, Brochner AC, Strom T, Andersen LW, Christensen S, Rasmussen BS, Schjorring OL, Maagaard M, Moller MH, Granholm A. Platform trials. Ugeskr Laeger. 2023 Oct 9;185(41):V04230237. Danish.

  PMID: 37873986 BACKGROUND

• Thorlund K, Park JJH, Wise MP, Doleman B, Petersen JJ, Lange T, Mathiesen O, Skrifvars MB, Saxena M, Nielsen N, Mills EJ, Grand J, Jakobsen JC. Logistical Challenges in Platform Randomized Trials - Operational Realities That Curb the Promise of Efficiency. Clin Epidemiol. 2026 May 11;18:580997. doi: 10.2147/CLEP.S580997. eCollection 2026.

  PMID: 42147735 BACKGROUND

• Saville BR, Berry SM. Efficiencies of platform clinical trials: A vision of the future. Clin Trials. 2016 Jun;13(3):358-66. doi: 10.1177/1740774515626362. Epub 2016 Feb 17.

  PMID: 26908536 BACKGROUND

• Park JJH, Detry MA, Murthy S, Guyatt G, Mills EJ. How to Use and Interpret the Results of a Platform Trial: Users' Guide to the Medical Literature. JAMA. 2022 Jan 4;327(1):67-74. doi: 10.1001/jama.2021.22507.

  PMID: 34982138 BACKGROUND

• Roustit M, Demarcq O, Laporte S, Barthelemy P, Chassany O, Cucherat M, Demotes J, Diebolt V, Esperou H, Fouret C, Galaup A, Gambotti L, Gourio C, Guerin A, Labruyere C, Paoletti X, Porcher R, Simon T, Varoqueaux N. Les essais plateformes. Therapie. 2023 Jan-Feb;78(1):19-28. doi: 10.1016/j.therap.2022.11.011. Epub 2022 Dec 5. French.

  PMID: 36581520 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators will be blinded to treatment allocation and block sizes whenever possible. Measures will be implemented to prevent the dissemination of information regarding treatment allocation beyond the immediate group of caregivers responsible for patient care when blinding is not feasible (e.g., domains investigating two different revascularisation methods). Outcome assessors, statisticians, and data managers will remain blinded to treatment allocation. Where feasible, all members of the steering group and manuscript author will also remain blinded to treatment allocation. However, in some domains, blinding of operators and interventional cardiologists is not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Platform trials are clinical trials that focus on a specific disease or patient population. Unlike traditional clinical trials, which typically evaluate the effect of a single intervention and conclude once a predefined sample size is reached, platform trials use shared infrastructure to assess multiple domains simultaneously. This can be done through a factorial design, in which interventions are evaluated in parallel or sequentially via continued randomisation. The goal is to address multiple research questions within a single trial framework.This approach allows a platform trial to leverage existing infrastructure, enabling researchers to address their questions with fewer resources.

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2044
• Study Completion (Estimated): January 1, 2044
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At the end of the trial
• Access Criteria: In peer-review papers

Locations

DK (1); NL (1); BE (1)