Everolimus Stent in Myocardial Infarction (RaCES-MI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01684982

Recruitment Status : Completed

First Posted : September 13, 2012

Last Update Posted : April 4, 2013

Sponsor:

Information provided by (Responsible Party):

Emilio Di Lorenzo MD PhD, San Giuseppe Moscati Hospital

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Acute Myocardial Infarction	Device: everolimus eluting stent Device: sirolimus eluting stent	Phase 4

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

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	500 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction (STEMI) (RaCES-MI Trial)
Study Start Date :	April 2007
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: everolimus eluting stent second generation drug eluting stent	Device: everolimus eluting stent experimental arm of a comparison between drug eluting stents Other Name: XIENCE V Abbott Vascular
Active Comparator: sirolimus eluting stent first generation drug eluting stent	Device: sirolimus eluting stent control arm of a comparison between drug eluting stents Other Name: CYPHER Johnson & Johnson

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis [ Time Frame: 36 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684982

Locations


Italy
Division of Cardiology AO Moscati
Avellino, Italy, 83100

Sponsors and Collaborators

San Giuseppe Moscati Hospital

Investigators


Principal Investigator:	EMILIO DI LORENZO, MD PHD	AO MOSCATI AVELLINO ITALY
Study Director:	ROSARIO SAURO, MD	AO MOSCATI AVELLINO ITALY

More Information

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, Díaz 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. Review.

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. Review.

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, Schömig 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.

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.

Hofma SH, Brouwer J, Velders MA, van't Hof AW, Smits PC, Queré 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.

Sabate M, Cequier A, Iñiguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gómez-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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Emilio Di Lorenzo MD PhD, Chief Interventional Cardiology, San Giuseppe Moscati Hospital
ClinicalTrials.gov Identifier:	NCT01684982 History of Changes
Other Study ID Numbers:	DiLOR_2012
First Posted:	September 13, 2012 Key Record Dates
Last Update Posted:	April 4, 2013
Last Verified:	April 2013

Keywords provided by Emilio Di Lorenzo MD PhD, San Giuseppe Moscati Hospital:


Primary PCI Drug Eluting Stent

Additional relevant MeSH terms:


Infarction Myocardial Infarction ST Elevation Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases	Everolimus Sirolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents

To Top