Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI

ST Elevation Myocardial Infarction Clinical Trial

— COPERNICAN  

Official title:

Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06353594
• Other study ID #: COPERNICAN TRIAL
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: September 2035

Study information

• Verified date: April 2024
• Source: Hospital Universitario La Fe
• Contact: Naiara García Lamas
• Phone: 634213101
• Email: naiara[@]pinvestiga.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1272
• Est. completion date: September 2035
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Device:
• Primary PCI
Coronary percutaneous revascularization

Locations

Country	Name	City	State
Spain	Consorcio Hospitalario Provincial de Castellon	Castelló
Spain	Hospital General Universitario de Elche	Elche
Spain	Hospital Universitari de Bellvitge	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	Sevilla
Spain	Hospital Universitari Joan Xxiii de Tarragona	Tarragona
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Spain	Hospital Universitario Y Politecnico La Fe	Valencia	Comunidad Valenciana
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Jorge Sanz Sanchez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure (TLF)	Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization	12 months
Secondary	Incidence of all-cause death	Physicians Assessment	10 years
Secondary	Incidence of myocardial infarction	Physicians Assessment	10 years
Secondary	Incidence of cardiovascular death	Physicians Assessment	10 years
Secondary	Incidence of target lesion revascularization	Physicians Assessment	10 years
Secondary	Incidence of stent thrombosis	Physicians Assessment	10 years
Secondary	Incidence of acute vessel closure	Physicians Assessment	10 years
Secondary	Incidence of stroke	Physicians Assessment	10 years
Secondary	Incidence of acute kidney injury	Physicians Assessment	10 years
Secondary	Incidence of bleeding	Physicians Assessment	10 years