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

August 16, 2010 updated by: San Giuseppe Moscati Hospital

Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With Coronary Artery Disease

Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Avellino, Italy, 83100
        • Division of Cardiology Aorn Moscati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EES Group
Patients who received an everolimus eluting stent
Device: coronary stent
coronary angioplasty with stent implantation
Other Names:
  • XIENCE V drug eluting stent; Abbot Vascular USA
Active Comparator: SES Gruop
Patients who received a sirolimus eluting stent
Device: stent
coronary angioplasty with stent implantation
Other Names:
  • CYPHER drug eluting stent; Johnson & Johnson USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Vessel Revascularization
Time Frame: 2 year
Incidence of clinically driven target vessel revascularization at 2 year follow up
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac death
Time Frame: 2 year
incidence of death for cardiac causes at 2 year
2 year
non fatal myocardial infarction
Time Frame: 2 year
incidence of non fatal Q or non Q wave reinfarction at 2 year
2 year
stent thrombosis
Time Frame: 2 year
incidence of definite, probable or possible stent thrombosis at 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Giuseppe Moscati Hospital

Investigators

  • Principal Investigator: EMILIO DI LORENZO, MD PhD, DIVISION OF CARDIOLOGY AORN MOSCATI AVELLINO ITALY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

August 16, 2010

First Posted (Estimate)

August 17, 2010

Study Record Updates

Last Update Posted (Estimate)

August 17, 2010

Last Update Submitted That Met QC Criteria

August 16, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM_DES02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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