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NCT Number: NCT06353594

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

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).

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Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Juan Ramón Jiménez, Huelva, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary PCI

Device

Coronary percutaneous revascularization

Primary outcomes

  1. Target lesion failure (TLF)

    Time frame: 12 months

    Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

Secondary outcomes

  1. Incidence of all-cause death

    Time frame: 10 years

    Physicians Assessment

  2. Incidence of myocardial infarction

    Time frame: 10 years

    Physicians Assessment

  3. Incidence of cardiovascular death

    Time frame: 10 years

    Physicians Assessment

  4. Incidence of target lesion revascularization

    Time frame: 10 years

    Physicians Assessment

  5. Incidence of stent thrombosis

    Time frame: 10 years

    Physicians Assessment

  6. Incidence of acute vessel closure

    Time frame: 10 years

    Physicians Assessment

  7. Incidence of stroke

    Time frame: 10 years

    Physicians Assessment

  8. Incidence of acute kidney injury

    Time frame: 10 years

    Physicians Assessment

  9. Incidence of bleeding

    Time frame: 10 years

    Physicians Assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Fernández Álvarez

CONTACT

[email protected]

604037828

Naiara García Lamas

CONTACT

[email protected]

634213101

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Fe

Other

Collaborators

  • ERA4Health

Registry information

Official study title

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

Acronym: COPERNICAN

Important dates

Study start
2024
Primary completion
2026
Study completion
2035
First posted
Apr 9, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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