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

This study has been completed.
Sponsor:
Information provided by:
San Giuseppe Moscati Hospital
ClinicalTrials.gov Identifier:
NCT01182649
First received: August 9, 2010
Last updated: August 16, 2010
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by San Giuseppe Moscati Hospital:

Primary Outcome Measures:
  • Target Vessel Revascularization [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    Incidence of clinically driven target vessel revascularization at 2 year follow up


Secondary Outcome Measures:
  • cardiac death [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    incidence of death for cardiac causes at 2 year

  • non fatal myocardial infarction [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    incidence of non fatal Q or non Q wave reinfarction at 2 year

  • stent thrombosis [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 9, 2010
Last Updated: August 16, 2010
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Sirolimus
Everolimus
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on October 17, 2012