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Everolimus Stent in Patients With Coronary Artery Disease (CAD) (RACES)

Primary Purpose

Coronary Artery Disease, Coronary Atherosclerosis

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
coronary stent
stent
Sponsored by
San Giuseppe Moscati Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug Eluting Stents, Everolimus Eluting Stent, Coronary Angioplasty

Eligibility Criteria

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

Inclusion Criteria:

  • All patients with coronary artery disease eligible for percutaneous coronary intervention (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

Sites / Locations

  • Division of Cardiology Aorn Moscati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EES Group

SES Gruop

Arm Description

Patients who received an everolimus eluting stent

Patients who received a sirolimus eluting stent

Outcomes

Primary Outcome Measures

Target Vessel Revascularization
Incidence of clinically driven target vessel revascularization at 2 year follow up

Secondary Outcome Measures

cardiac death
incidence of death for cardiac causes at 2 year
non fatal myocardial infarction
incidence of non fatal Q or non Q wave reinfarction at 2 year
stent thrombosis
incidence of definite, probable or possible stent thrombosis at 2 year

Full Information

First Posted
August 9, 2010
Last Updated
August 16, 2010
Sponsor
San Giuseppe Moscati Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01182649
Brief Title
Everolimus Stent in Patients With Coronary Artery Disease (CAD)
Acronym
RACES
Official Title
Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
San Giuseppe Moscati Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients
Detailed Description
Compared with the currently available first-generation drug-eluting stents (DES), second-generation DES have been designed with the goal of improving safety and efficacy. Everolimus, a sirolimus analogue, is released from a open cell, thin-strut, cobalt-chromium frame. A significant reduction in cardiac events was noted in patients with the everolimus-eluting stent compared with those who had a paclitaxel-eluting stent. Sirolimus eluting stent was the first available drug eluting stent and is the most tested. Therefore the investigators compared the safety and efficacy of the everolimus-eluting and sirolimus eluting stents in unselected patients in real world practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Atherosclerosis
Keywords
Drug Eluting Stents, Everolimus Eluting Stent, Coronary Angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EES Group
Arm Type
Experimental
Arm Description
Patients who received an everolimus eluting stent
Arm Title
SES Gruop
Arm Type
Active Comparator
Arm Description
Patients who received a sirolimus eluting stent
Intervention Type
Device
Intervention Name(s)
coronary stent
Other Intervention Name(s)
XIENCE V drug eluting stent; Abbot Vascular USA
Intervention Description
coronary angioplasty with stent implantation
Intervention Type
Device
Intervention Name(s)
stent
Other Intervention Name(s)
CYPHER drug eluting stent; Johnson & Johnson USA
Intervention Description
coronary angioplasty with stent implantation
Primary Outcome Measure Information:
Title
Target Vessel Revascularization
Description
Incidence of clinically driven target vessel revascularization at 2 year follow up
Time Frame
2 year
Secondary Outcome Measure Information:
Title
cardiac death
Description
incidence of death for cardiac causes at 2 year
Time Frame
2 year
Title
non fatal myocardial infarction
Description
incidence of non fatal Q or non Q wave reinfarction at 2 year
Time Frame
2 year
Title
stent thrombosis
Description
incidence of definite, probable or possible stent thrombosis at 2 year
Time Frame
2 year

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 patients with coronary artery disease eligible for percutaneous coronary intervention (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
DIVISION OF CARDIOLOGY AORN MOSCATI AVELLINO ITALY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology Aorn Moscati
City
Avellino
ZIP/Postal Code
83100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20445180
Citation
Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496.
Results Reference
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PubMed Identifier
20060578
Citation
Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.
Results Reference
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PubMed Identifier
19712798
Citation
Caixeta A, Leon MB, Lansky AJ, Nikolsky E, Aoki J, Moses JW, Schofer J, Morice MC, Schampaert E, Kirtane AJ, Popma JJ, Parise H, Fahy M, Mehran R. 5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J Am Coll Cardiol. 2009 Sep 1;54(10):894-902. doi: 10.1016/j.jacc.2009.04.077.
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
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Everolimus Stent in Patients With Coronary Artery Disease (CAD)

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