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Everolimus Stent in Myocardial Infarction (RaCES-MI)

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
everolimus eluting stent
sirolimus eluting stent
Sponsored by
San Giuseppe Moscati Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Primary PCI, Drug Eluting Stent

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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.

Sites / Locations

  • Division of Cardiology AO Moscati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

everolimus eluting stent

sirolimus eluting stent

Arm Description

second generation drug eluting stent

first generation drug eluting stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2012
Last Updated
April 1, 2013
Sponsor
San Giuseppe Moscati Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01684982
Brief Title
Everolimus Stent in Myocardial Infarction
Acronym
RaCES-MI
Official Title
Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction (STEMI) (RaCES-MI Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Giuseppe Moscati Hospital

4. Oversight

Data Monitoring Committee
No

5. 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)
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Primary PCI, Drug Eluting Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
everolimus eluting stent
Arm Type
Experimental
Arm Description
second generation drug eluting stent
Arm Title
sirolimus eluting stent
Arm Type
Active Comparator
Arm Description
first generation drug eluting stent
Intervention Type
Device
Intervention Name(s)
everolimus eluting stent
Other Intervention Name(s)
XIENCE V Abbott Vascular
Intervention Description
experimental arm of a comparison between drug eluting stents
Intervention Type
Device
Intervention Name(s)
sirolimus eluting stent
Other Intervention Name(s)
CYPHER Johnson & Johnson
Intervention Description
control arm of a comparison between drug eluting stents
Primary Outcome Measure Information:
Title
cardiac death, reinfarction and Target Vessel Revascularization (TVR)
Description
Any death of cardiac origin, any myocardial infarction and any new revascularization of the infarct related artery
Time Frame
36 MONTHS
Secondary Outcome Measure Information:
Title
cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIO DI LORENZO, MD PHD
Organizational Affiliation
AO MOSCATI AVELLINO ITALY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ROSARIO SAURO, MD
Organizational Affiliation
AO MOSCATI AVELLINO ITALY
Official's Role
Study Director
Facility Information:
Facility Name
Division of Cardiology AO Moscati
City
Avellino
ZIP/Postal Code
83100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22529227
Citation
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.
Results Reference
background
PubMed Identifier
21792636
Citation
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.
Results Reference
background
PubMed Identifier
20221617
Citation
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.
Results Reference
background
PubMed Identifier
19781402
Citation
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.
Results Reference
background
PubMed Identifier
22835668
Citation
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.
Results Reference
background
PubMed Identifier
22951305
Citation
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.
Results Reference
background
PubMed Identifier
25147029
Citation
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.
Results Reference
derived

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Everolimus Stent in Myocardial Infarction

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