ST Elevation Myocardial InfarctionCOPERNICANNCT06353594
Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI
A study testing Primary PCI in people with ST Elevation Myocardial Infarction, run by Hospital Universitario La Fe at 23 sites in Spain.
Trial summary
The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- Primary PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,272 participants
- Where
- 23 sitesSpain
- Study dates
- 11 Mar 2024to Sep 2035
- 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
- Patients presenting with STEMI and indication to undergo pPCI.
Who cannot join
- Life expectancy <1 year due 1 to non-cardiac disease.
- Inability to provide informed consent.
- Cardiogenic shock.
- Left ventricular ejection fraction <15%.
- Left main disease.
- Stent thrombosis
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- Patients with prior bypass graft lesions requiring PCI (culprit or non culprit lesions).
- Patients with chronic total occlusions.
- Untreatable coronary disease.
- Non-identified culprit lesion.
- Known allergy to aspirin, ticagrelor, prasugrel, clopidogrel, paclitaxel or sirolimus.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
Spain23 sites, 23 recruiting
- Recruiting
Complejo Hospitalario Universitario de A Coruña
A Coruña
Pablo Piñón
- Recruiting
Hospital Universitario de Burgos
Burgos
Jean Núñez
- Recruiting
Consorcio Hospitalario Provincial de Castellon
Castelló
Vicente Pernías Escrig, PI
- Recruiting
Hospital Universitario Reina Sofía de Córdoba
Córdoba
Soledad Ojeda
- Recruiting
Hospital General Universitario de Elche
Elche
Pedro Morillas, PI
- Recruiting
Hospital Universitario Clínico San Cecilio
Granada
- Recruiting
Hospital Universitario Juan Ramón Jiménez
Huelva, Huelva
ANTONIO E GÓMEZ MENCHERO, PI
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
Neus Salvatella Giralt, PI
- Recruiting
Hospital Universitario de La Princesa
Madrid
Fernando Rivero Crespo, PI
- Recruiting
Hospital Universitario La Paz
Madrid
Alfonso Jurado Román
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Madrid
Juan F Oteo Domínguez, PI
- Recruiting
Hospital Universitario Regional de Malaga
Málaga
Cristobal Urbano Carrillo, PI
- Recruiting
Hospital de Mérida
Mérida
Eladio Galindo
- Recruiting
Hospital Universitario de Navarra
Pamplona
Guillermo Sánchez Elvira, PI
- Recruiting
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela
Alfredo Redondo
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville
José Díaz Fernández, PI
- Recruiting
Hospital Universitari Joan Xxiii de Tarragona
Tarragona
Mauricio Torres Sánchez, PI
- Recruiting
Hospital Universitario Mutua de Terrassa
Terrassa
Juan Sánchez
- Recruiting
Hospital Universitario Y Politecnico La Fe
Valencia, Valencia
Jorge Sanz Sánchez, PI
- Recruiting
Consorcio Hospital General Universitario de Valencia
Valencia
Eva Rumiz González, PI
- Recruiting
Hospital Clinico Universitario de Valladolid
Valladolid
Ignacio J Amat Santos, PI
- Recruiting
Hospital Clinico Universitario Lozano Blesa
Zaragoza
Antonela Lukic Otanovic, PI
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza
Georgina A Fuertes Ferre
About this study
Official title: Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)
The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).
Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:
- Study group: reduced stent PCI strategy (DCB-based)
- Control group: conventional PCI strategy (DES-based).
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Primary PCI
- Keywords
- STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary PCIDevice
Coronary percutaneous revascularization
| Study group | Role | What they receive |
|---|---|---|
| DCB-based | Experimental | Reduced stent PCI strategy: Culprit lesion revascularization with DCB will be performed after coronary predilation if residual stenosis ≤30%, lack of dissections >type B and TIMI 3 flow. If the aforementioned culprit-lesion characteristics are not achieved after DCB-PCI, a DES will be implanted. Receives: Device: Primary PCI |
| DES-based | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure (TLF)
Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization
Measured: 12 months
Secondary outcomes (9)
Incidence of all-cause death
Physicians Assessment
Measured: 10 years
Incidence of myocardial infarction
Physicians Assessment
Measured: 10 years
Incidence of cardiovascular death
Physicians Assessment
Measured: 10 years
Incidence of target lesion revascularization
Physicians Assessment
Measured: 10 years
Incidence of stent thrombosis
Physicians Assessment
Measured: 10 years
Incidence of acute vessel closure
Physicians Assessment
Measured: 10 years
Incidence of stroke
Physicians Assessment
Measured: 10 years
Incidence of acute kidney injury
Physicians Assessment
Measured: 10 years
Incidence of bleeding
Physicians Assessment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start11 Mar 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies 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
- Masking
- None (open label)
- Enrolment
- 1,272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- ERA4Health
- Responsible party
- Principal investigator, Jorge Sanz Sanchez, Hospital Universitario La Fe
- Investigators
- Jorge Sanz Sánchez, PI, Principal investigator, Hospital Universitario La FeIgnacio J Amat Santos, PI, Principal investigator, Hospital Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353594
- Sponsor's protocol ID
- COPERNICAN TRIAL
- Acronym
- COPERNICAN
- Status last verified
- May 2026
- First submitted
- 14 Mar 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanz-Sanchez J, Santos Martinez S, Rumiz Gonzalez E, Oteo Dominguez JF, Tejada Ponce D, Gomez Menchero A, Sanchez Elvira G, Fuertes Ferre G, Rivero Crespo F, Lukic Otanovic A, Diaz Fernandez J, Galindo Fernandez E, Urbano Carrillo C, Salvatella Giralt N, Torres Sanchez M, Garcia Touchard A, Ibanez Cabeza B, Stefanini G, Alfonso Manterola F, Garcia Garcia H, Amat-Santos IJ. Reduced stent strategy versus conventional percutaneous coronary revascularization in patients presenting with STEMI: design of the COPERNICAN trial. Rev Esp Cardiol (Engl Ed). 2026 Feb;79(2):100-105. doi: 10.1016/j.rec.2025.05.005. Epub 2025 May 22. English, Spanish.
PubMed 40412715
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)
- ClinicalTrials.gov ID
- NCT06353594
- Acronym / sponsor ID
- COPERNICAN / COPERNICAN TRIAL
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- STEMI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,272 participants (estimated)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Collaborators
- ERA4Health
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2035 (estimated)
- First posted
- 9 Apr 2024 (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.
The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).
Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:
- Study group: reduced stent PCI strategy (DCB-based)
- Control group: conventional PCI strategy (DES-based).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB-based | Experimental | Device: Primary PCIReduced stent PCI strategy: Culprit lesion revascularization with DCB will be performed after coronary predilation if residual stenosis ≤30%, lack of dissections >type B and TIMI 3 flow. If the aforementioned culprit-lesion characteristics are not achieved after DCB-PCI, a DES will be implanted. |
| DES-based | No intervention | –Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting with STEMI and indication to undergo pPCI.
Key exclusion criteria (11 listed)
- Life expectancy <1 year due 1 to non-cardiac disease.
- Inability to provide informed consent.
- Cardiogenic shock.
- Left ventricular ejection fraction <15%.
- Left main disease.
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 |
|---|---|---|
| Primary PCICoronary percutaneous revascularization | Device | DCB-based |
Primary outcome
Target lesion failure (TLF)
Time frame: 12 months
Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization
9 secondary outcomes
Incidence of all-cause death
Time frame: 10 years
Incidence of myocardial infarction
Time frame: 10 years
Incidence of cardiovascular death
Time frame: 10 years
Incidence of target lesion revascularization
Time frame: 10 years
Incidence of stent thrombosis
Time frame: 10 years
Incidence of acute vessel closure
Time frame: 10 years
Incidence of stroke
Time frame: 10 years
Incidence of acute kidney injury
Time frame: 10 years
Incidence of bleeding
Time frame: 10 years
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 28 May 2026.
- Derived from this study: PubMed 40412715Sanz-Sanchez J, Santos Martinez S, Rumiz Gonzalez E, Oteo Dominguez JF, Tejada Ponce D, Gomez Menchero A, Sanchez Elvira G, Fuertes Ferre G, Rivero Crespo F, Lukic Otanovic A, Diaz Fernandez J, Galindo Fernandez E, Urbano Carrillo C, Salvatella Giralt N, Torres Sanchez M, Garcia Touchard A, Ibanez Cabeza B, Stefanini G, Alfonso Manterola F, Garcia Garcia H, Amat-Santos IJ. Reduced stent strategy versus conventional percutaneous coronary revascularization in patients presenting with STEMI: design of the COPERNICAN trial. Rev Esp Cardiol (Engl Ed). 2026 Feb;79(2):100-105. doi: 10.1016/j.rec.2025.05.005. Epub 2025 May 22. English, Spanish.
- Individual participant dataSharing planned: No
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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.
Jorge Sanz Sánchez, PI principal investigator
Hospital Universitario La Fe
Ignacio J Amat Santos, PI principal investigator
Hospital Universitario de Valladolid
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary PCI in people with ST Elevation Myocardial Infarction, run by Hospital Universitario La Fe at 23 sites in Spain.
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 1 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Spain. 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?
Contact Naiara García Lamas (634213101, naiara@pinvestiga.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (TLF) (time frame: 12 months). 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 NCT06353594, which also lists 1 linked publication.
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 28 May 2026.