Coronary RevascularizationCORENCT07892976
The CORE Platform Trial
A study testing MIDCAB procedure and CABG procedure in people with Coronary Revascularization and Coronary Artery Disease, run by Copenhagen Trial Unit, Center for Clinical Intervention Research at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Revascularization, Coronary Artery Disease
- What is being tested?
- MIDCAB procedure and CABG procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Jan 2027to Jan 2044
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Separate exclusion criteria will be defined for each randomised comparison in the platform.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Belgium1 site
UZ Leuven
Leuven
Wouter Oosterlinck, MD, Professor, 3216379282, wouter.oosterlinck@kuleuven.be
Denmark1 site
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Capital Region, 2100
Erika Nodin, MD, 004535451172, enod0001@regionh.dk
Netherlands1 site
UMC Utrecht
Utrecht
Monica Gianoli, MD, PhD, 31887555555, m.gianoli@umcutrecht.nl
About this study
Official title: 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 (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.
- Being tested
- MIDCAB procedure, CABG procedure
- Keywords
- Platform trial, Coronary revascularization, Master protocol
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIDCAB procedureProcedure or surgery
Also called Hybrid revascularisation
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 procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: CABG procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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.
Measured: 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
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completionJan 2044 (estimated)
- Study completionJan 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary RevascularizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, UMC Utrecht, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892976
- Sponsor's protocol ID
- CORE-PLATFORM (CORE-DP-593)
- Acronym
- CORE
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make all data publicly available in peer-review papers, after the trial has been finalized.
Publications
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.
PubMed 37873986Thorlund 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.
PubMed 42147735Saville 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.
PubMed 26908536Park 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.
PubMed 34982138Roustit 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.
PubMed 36581520
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COronary REvascularisation Platform Trial: Study Master Protocol for a Platform Trial
- ClinicalTrials.gov ID
- NCT07892976
- Acronym / sponsor ID
- CORE / CORE-PLATFORM (CORE-DP-593)
- Keywords
- Platform trial, Coronary revascularization, Master protocol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention ResearchUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, UMC Utrecht, Universitaire Ziekenhuizen KU Leuven
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Jan 2044 (estimated)
- Study completion
- Jan 2044 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive direct coronary artery bypass (MIDCAB) procedure | Experimental | Procedure: MIDCAB procedureThe 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. |
| Conventional coronary artery bypass grafting (CABG) procedure | Active comparator | Procedure: CABG procedureCABG 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Separate exclusion criteria will be defined for each randomised comparison in the platform.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIDCAB procedureAlso: Hybrid revascularisationThe 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 or surgery | Minimally invasive direct coronary artery bypass (MIDCAB) procedure |
| CABG procedureCoronary 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. | Procedure or surgery | Conventional coronary artery bypass grafting (CABG) procedure |
Primary outcome
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)
Time frame: 12 months after randomization
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.
3 secondary outcomes
Angina symptoms (an example of a secondary outcome used in the first randomised comparison in the CORE Platform Trial).
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).
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).
Time frame: 90 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 37873986Perner 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.
- Background: PubMed 42147735Thorlund 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.
- Background: PubMed 26908536Saville 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.
- Background: PubMed 34982138Park 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.
- Background: PubMed 36581520Roustit 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.
- Individual participant dataSharing planned: Yes. We plan to make all data publicly available in peer-review papers, after the trial has been finalized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIDCAB procedure and CABG procedure in people with Coronary Revascularization and Coronary Artery Disease, run by Copenhagen Trial Unit, Center for Clinical Intervention Research at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Denmark, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07892976, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.