Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI
COPERNICAN
1 other identifier
interventional
1,272
1 country
15
Brief 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). 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2024
CompletedFirst Submitted
Initial submission to the registry
March 14, 2024
CompletedFirst Posted
Study publicly available on registry
April 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2035
April 9, 2024
April 1, 2024
2.5 years
March 14, 2024
April 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target lesion failure (TLF)
Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization
12 months
Secondary Outcomes (9)
Incidence of all-cause death
10 years
Incidence of myocardial infarction
10 years
Incidence of cardiovascular death
10 years
Incidence of target lesion revascularization
10 years
Incidence of stent thrombosis
10 years
- +4 more secondary outcomes
Study Arms (2)
DCB-based
EXPERIMENTALReduced 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 INTERVENTIONControl group
Interventions
Eligibility Criteria
You may qualify if:
- \- Patients presenting with STEMI and indication to undergo pPCI.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Hospital Universitario Y Politecnico La Fe
Valencia, Valencia, Spain
Consorcio Hospitalario Provincial de Castellon
Castelló, Spain
Hospital General Universitario de Elche
Elche, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
Hospital Universitario Regional de Malaga
Málaga, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Universitari Joan Xxiii de Tarragona
Tarragona, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Related Publications (1)
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: the COPERNICAN trial. Rev Esp Cardiol (Engl Ed). 2025 May 22:S1885-5857(25)00150-1. doi: 10.1016/j.rec.2025.05.005. Online ahead of print. English, Spanish.
PMID: 40412715DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge Sanz Sánchez, PI
Hospital Universitario La Fe
- PRINCIPAL INVESTIGATOR
Ignacio J Amat Santos, PI
Hospital Universitario de Valladolid
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Interventional cardiologist
Study Record Dates
First Submitted
March 14, 2024
First Posted
April 9, 2024
Study Start
March 11, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2035
Last Updated
April 9, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share