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Completed

NCT Number: NCT01684982

Everolimus Stent in Myocardial Infarction

Randomized trial to test the efficacy and safety of newer Drug Eluting Stent generation in patient with acute myocardial infarction treated with primary percutaneous coronary intervention (PCI)

Completed

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology AO Moscati

Avellino, 83100, Italy

About this study

The efficacy and safety of drug-eluting stents (DES) in the treatment of coronary artery disease is well established. It is well known that Drug Eluting Stent (DES) have dramatically decreased Restenosis rates for both on-label and off-label indications. However, the concern for increased (late) stent thrombosis is still present DES implantation in patient with acute myocardial infarction is still controversial because acute coronary lesion presents the highest possible thrombotic burden Newer DES with new antiproliferative drugs and more biocompatible polymers have shown a significant reduction of (late) stent thrombosis in patients in stable condition.

Aim of the study was to asses the long term efficacy and safety on second generation everolimus eluting stent compared with first generation sirolimus eluting stent

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All ST segment elevation myocardial infarction (STEMI) patients eligible for primary PCI

Exclusion criteria

  • Contraindication to dual antiplatelet therapy for 12 months
  • Known allergy to sirolimus or everolimus
  • Major surgical procedure planned within 1 month.
  • History, symptoms, or findings suggestive of aortic dissection.
  • Participation in other trials
  • Pregnancy.

Treatment and study plan

Everolimus Eluting Stent

Device

experimental arm of a comparison between drug eluting stents

Other names: XIENCE V Abbott Vascular

Sirolimus eluting stent

Device

control arm of a comparison between drug eluting stents

Other names: CYPHER Johnson & Johnson

Primary outcomes

  1. cardiac death, reinfarction and Target Vessel Revascularization (TVR)

    Time frame: 36 MONTHS

    Any death of cardiac origin, any myocardial infarction and any new revascularization of the infarct related artery

Secondary outcomes

  1. cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

San Giuseppe Moscati Hospital

Other

Registry information

Official study title

Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction (STEMI) (RaCES-MI Trial)

Acronym: RaCES-MI

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2012
Registry last updated
Apr 4, 2013

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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