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

April 2, 2024 updated by: Jorge Sanz Sanchez

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Castelló, Spain
        • Not yet recruiting
        • Consorcio Hospitalario Provincial de Castellón
        • Contact:
          • David Tejada Ponce, PI
      • Elche, Spain
        • Not yet recruiting
        • Hospital General Universitario de Elche
        • Contact:
          • Paula Tejedor Viñuela, PI
      • Hospitalet de Llobregat, Spain
        • Not yet recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
          • Neus Salvatella Giralt, PI
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario 12 de octubre
        • Contact:
          • Fernando Sarnago Cebada, PI
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Contact:
          • Juan F Oteo Domínguez, PI
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario de la Princesa
        • Contact:
          • Fernando Rivero Crespo, PI
      • Málaga, Spain
        • Not yet recruiting
        • Hospital Universitario Regional de Málaga
        • Contact:
          • Cristobal Urbano Carrillo, PI
      • Pamplona, Spain
        • Not yet recruiting
        • Hospital Universitario de Navarra
        • Contact:
          • Guillermo Sánchez Elvira, PI
      • Sevilla, Spain
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
          • José Díaz Fernández, PI
      • Tarragona, Spain
        • Not yet recruiting
        • Hospital Universitari Joan Xxiii de Tarragona
        • Contact:
          • Mauricio Torres Sánchez, PI
      • Valencia, Spain
        • Recruiting
        • Consorcio Hospital General Universitario de Valencia
        • Contact:
          • Eva Rumiz González, PI
      • Valladolid, Spain
        • Not yet recruiting
        • Hospital Clínico Universitario de Valladolid
        • Contact:
          • Ignacio J Amat Santos, PI
      • Zaragoza, Spain
        • Not yet recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
          • Georgina A Fuertes Ferre
      • Zaragoza, Spain
        • Not yet recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Contact:
          • Antonela Lukic Otanovic, PI
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain
        • Recruiting
        • Hospital Universitario y Politécnico La Fe
        • Contact:
          • Jorge Sanz Sánchez, PI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCB-based
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.
Device: Primary PCI
Coronary percutaneous revascularization
No Intervention: DES-based
Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion failure (TLF)
Time Frame: 12 months
Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all-cause death
Time Frame: 10 years
Physicians Assessment
10 years
Incidence of myocardial infarction
Time Frame: 10 years
Physicians Assessment
10 years
Incidence of cardiovascular death
Time Frame: 10 years
Physicians Assessment
10 years
Incidence of target lesion revascularization
Time Frame: 10 years
Physicians Assessment
10 years
Incidence of stent thrombosis
Time Frame: 10 years
Physicians Assessment
10 years
Incidence of acute vessel closure
Time Frame: 10 years
Physicians Assessment
10 years
Incidence of stroke
Time Frame: 10 years
Physicians Assessment
10 years
Incidence of acute kidney injury
Time Frame: 10 years
Physicians Assessment
10 years
Incidence of bleeding
Time Frame: 10 years
Physicians Assessment
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jorge Sanz Sanchez

Investigators

  • Principal Investigator: Jorge Sanz Sánchez, PI, Hospital Universitario La Fe
  • Principal Investigator: Ignacio J Amat Santos, PI, Hospital Universitario de Valladolid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2035

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPERNICAN TRIAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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