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CompletedNCT01684982RaCES-MIUpdated Apr 4, 2013

Everolimus Stent in Myocardial Infarction

A Phase 4 interventional study of everolimus eluting stent and sirolimus eluting stent in Acute Myocardial Infarction, sponsored by San Giuseppe Moscati Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-04-04.

Sponsored by San Giuseppe Moscati Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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)

Read the detailed description

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

02

Conditions studied

  • Acute Myocardial Infarction

Keywords

  • Primary PCI
  • Drug Eluting Stent
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 500 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

San Giuseppe Moscati Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Contraindication to dual antiplatelet therapy for 12 months
  2. Known allergy to sirolimus or everolimus
  3. Major surgical procedure planned within 1 month.
  4. History, symptoms, or findings suggestive of aortic dissection.
  5. Participation in other trials
  6. Pregnancy.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (actual)

Study arms

  • Experimental
    everolimus eluting stent

    second generation drug eluting stent

    Device: everolimus eluting stent

  • Active comparator
    sirolimus eluting stent

    first generation drug eluting stent

    Device: sirolimus eluting stent

Interventions

  • Deviceeverolimus eluting stent

    experimental arm of a comparison between drug eluting stents

    Also known as: XIENCE V Abbott Vascular

  • Devicesirolimus eluting stent

    control arm of a comparison between drug eluting stents

    Also known as: CYPHER Johnson & Johnson

06

What researchers measure

Primary outcomes

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

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

    Time frame: 36 MONTHS

Secondary outcomes

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

    Time frame: 36 months

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Study locations

1 site
  • Division of Cardiology AO Moscati
    Avellino, 83100, Italy
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References and documents

Publications

  • De Luca G, Dirksen MT, Spaulding C, Kelbaek H, Schalij M, Thuesen L, van der Hoeven B, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, Diaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Cortese G, Suryapranata H, Stone GW; Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med. 2012 Apr 23;172(8):611-21; discussion 621-2. doi: 10.1001/archinternmed.2012.758. PubMed 22529227 ↗
  • Di Lorenzo E, Carbone G, Sauro L, Casafina A, Capasso M, Sauro R. Bare-metal stents versus drug-eluting stents for primary angioplasty: long-term outcome. Curr Cardiol Rep. 2011 Oct;13(5):459-64. doi: 10.1007/s11886-011-0207-0. PubMed 21792636 ↗
  • Dibra A, Tiroch K, Schulz S, Kelbaek H, Spaulding C, Laarman GJ, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Campo G, Thuesen L, Vink MA, Schalij MJ, Violini R, Schomig A, Kastrati A. Drug-eluting stents in acute myocardial infarction: updated meta-analysis of randomized trials. Clin Res Cardiol. 2010 Jun;99(6):345-57. doi: 10.1007/s00392-010-0133-y. Epub 2010 Mar 11. PubMed 20221617 ↗
  • Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016. PubMed 19781402 ↗
  • Hofma SH, Brouwer J, Velders MA, van't Hof AW, Smits PC, Quere M, de Vries CJ, van Boven AJ. Second-generation everolimus-eluting stents versus first-generation sirolimus-eluting stents in acute myocardial infarction. 1-year results of the randomized XAMI (XienceV Stent vs. Cypher Stent in Primary PCI for Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2012 Jul 31;60(5):381-7. doi: 10.1016/j.jacc.2012.01.073. PubMed 22835668 ↗
  • Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gomez-Hospital JA, Baz JA, Martin-Yuste V, van Geuns RJ, Alfonso F, Bordes P, Tebaldi M, Masotti M, Silvestro A, Backx B, Brugaletta S, van Es GA, Serruys PW. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012 Oct 27;380(9852):1482-90. doi: 10.1016/S0140-6736(12)61223-9. Epub 2012 Sep 3. PubMed 22951305 ↗
  • Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Carbone G, Lanni F, Pagliuca MR, Stanco G, Rosato G, Suryapranata H, De Luca G. Randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction: RACES-MI trial. JACC Cardiovasc Interv. 2014 Aug;7(8):849-56. doi: 10.1016/j.jcin.2014.02.016. PubMed 25147029 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01684982
Lead sponsor
San Giuseppe Moscati Hospital
Responsible party
Emilio Di Lorenzo MD PhD (Chief Interventional Cardiology, San Giuseppe Moscati Hospital) — Principal investigator
First posted
Sep 13, 2012
Start date
Apr 2007
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Apr 4, 2013

Study contacts

EMILIO DI LORENZO, MD PHD
principal investigator · AO MOSCATI AVELLINO ITALY
ROSARIO SAURO, MD
study director · AO MOSCATI AVELLINO ITALY

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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