Everolimus Stent in Myocardial Infarction

NCT01684982 | Completed Phase 4

• 1 other identifier: DiLOR_2012
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Acute Myocardial Infarction

Keywords

Primary PCI; Drug Eluting Stent

Outcome Measures

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

  36 MONTHS

Secondary Outcomes (1)

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

  36 months

Study Arms (2)

everolimus eluting stent

EXPERIMENTAL

second generation drug eluting stent

Device: everolimus eluting stent

sirolimus eluting stent

ACTIVE COMPARATOR

first generation drug eluting stent

Device: sirolimus eluting stent

Interventions

everolimus eluting stent DEVICE

experimental arm of a comparison between drug eluting stents

Also known as: XIENCE V Abbott Vascular

everolimus eluting stent

sirolimus eluting stent DEVICE

control arm of a comparison between drug eluting stents

Also known as: CYPHER Johnson & Johnson

sirolimus eluting stent

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Giuseppe Moscati Hospital: lead

Study Sites (1)

Division of Cardiology AO Moscati

Avellino, 83100, Italy

Location

Related Publications (7)

• 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.

  PMID: 22529227 BACKGROUND

• 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.

  PMID: 21792636 BACKGROUND

• 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.

  PMID: 20221617 BACKGROUND

• 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.

  PMID: 19781402 BACKGROUND

• 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.

  PMID: 22835668 BACKGROUND

• 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.

  PMID: 22951305 BACKGROUND

• 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.

  PMID: 25147029 DERIVED

Study Officials

• EMILIO DI LORENZO, MD PHD

  AO MOSCATI AVELLINO ITALY

  PRINCIPAL INVESTIGATOR

• ROSARIO SAURO, MD

  AO MOSCATI AVELLINO ITALY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Interventional Cardiology

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: April 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

IT (1)