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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01182649
First Posted: August 17, 2010
Last Update Posted: August 17, 2010
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.
Information provided by:
San Giuseppe Moscati Hospital
  Purpose
Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients

Condition Intervention Phase
Coronary Artery Disease Coronary Atherosclerosis Device: coronary stent Device: stent Phase 3

Study Type: Interventional
Study Design: 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 Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by San Giuseppe Moscati Hospital:

Primary Outcome Measures:
  • Target Vessel Revascularization [ Time Frame: 2 year ]
    Incidence of clinically driven target vessel revascularization at 2 year follow up


Secondary Outcome Measures:
  • cardiac death [ Time Frame: 2 year ]
    incidence of death for cardiac causes at 2 year

  • non fatal myocardial infarction [ Time Frame: 2 year ]
    incidence of non fatal Q or non Q wave reinfarction at 2 year

  • stent thrombosis [ Time Frame: 2 year ]
    incidence of definite, probable or possible stent thrombosis at 2 year


Enrollment: 600
Study Start Date: March 2007
Study Completion Date: June 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EES Group
Patients who received an everolimus eluting stent
Device: coronary stent
coronary angioplasty with stent implantation
Other Name: 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 Name: CYPHER drug eluting stent; Johnson & Johnson USA

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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): NCT01182649


Locations
Italy
Division of Cardiology Aorn Moscati
Avellino, Italy, 83100
Sponsors and Collaborators
San Giuseppe Moscati Hospital
Investigators
Principal Investigator: EMILIO DI LORENZO, MD PhD DIVISION OF CARDIOLOGY AORN MOSCATI AVELLINO ITALY
  More Information

Publications:
Responsible Party: EMILIO DI LORENZO MD PhD, DIVISION OF CARDIOLOGY AO MOSCATI
ClinicalTrials.gov Identifier: NCT01182649     History of Changes
Other Study ID Numbers: AOM_DES02
First Submitted: August 9, 2010
First Posted: August 17, 2010
Last Update Posted: August 17, 2010
Last Verified: May 2010

Keywords provided by San Giuseppe Moscati Hospital:
Drug Eluting Stents
Everolimus Eluting Stent
Coronary Angioplasty

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive 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