Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Primary PCI.
- Who it may be relevant to
- Registry conditions: ST Elevation Myocardial Infarction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)
Overview
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).
Interventions
- Device Primary PCI
Coronary percutaneous revascularization
Primary outcome measures
- Target lesion failure (TLF) [Time frame: 12 months]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
\- Patients presenting with STEMI and indication to undergo pPCI.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 23 centers
- Hospital Universitario Juan Ramón Jiménez — Huelva
- Hospital Universitario Y Politecnico La Fe — Valencia
- Complejo Hospitalario Universitario de A Coruña — A Coruña
- Hospital Universitario de Burgos — Burgos
- Consorcio Hospitalario Provincial de Castellon — Castelló
- Hospital Universitario Reina Sofía de Córdoba — Córdoba
- Hospital General Universitario de Elche — Elche
- Hospital Universitario Clínico San Cecilio — Granada
- … and 15 more centers
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 v PMID 40412715
Identifiers
NCT: NCT06353594 · COPERNICAN TRIAL