Clinical trial NCT06353594: Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI
Official title: Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: STEMI
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 1272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Target lesion failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of all-cause death
timeFrame: 10 years
measure: Incidence of myocardial infarction
timeFrame: 10 years
measure: Incidence of cardiovascular death
timeFrame: 10 years
measure: Incidence of target lesion revascularization
timeFrame: 10 years
measure: Incidence of stent thrombosis
timeFrame: 10 years
measure: Incidence of acute vessel closure
timeFrame: 10 years
measure: Incidence of stroke
timeFrame: 10 years
measure: Incidence of acute kidney injury
timeFrame: 10 years
measure: Incidence of bleeding
timeFrame: 10 years
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario Y Politecnico La Fe
state: Comunidad Valenciana
city: Castelló
country: Spain
facility: Consorcio Hospitalario Provincial de Castellon
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Malaga
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Tarragona
country: Spain
facility: Hospital Universitari Joan Xxiii de Tarragona
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital Universitario La Fe
name: Jorge Sanz Sánchez, PI
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Valladolid
name: Ignacio J Amat Santos, PI
role: PRINCIPAL_INVESTIGATOR
References: