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Completed

NCT Number: NCT01182649

Everolimus Stent in Patients With Coronary Artery Disease (CAD)

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Atherosclerosis Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Cardiology Aorn Moscati

Avellino, 83100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary stent

Device

coronary angioplasty with stent implantation

Other names: XIENCE V drug eluting stent; Abbot Vascular USA

stent

Device

coronary angioplasty with stent implantation

Other names: CYPHER drug eluting stent; Johnson & Johnson USA

Primary outcomes

  1. Target Vessel Revascularization

    Time frame: 2 year

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

Secondary outcomes

  1. cardiac death

    Time frame: 2 year

    incidence of death for cardiac causes at 2 year

  2. non fatal myocardial infarction

    Time frame: 2 year

    incidence of non fatal Q or non Q wave reinfarction at 2 year

  3. stent thrombosis

    Time frame: 2 year

    incidence of definite, probable or possible stent thrombosis at 2 year

Sponsors and collaborators

Lead sponsor

San Giuseppe Moscati Hospital

Other

Registry information

Official study title

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

Acronym: RACES

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Aug 17, 2010
Registry last updated
Aug 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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