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Everolimus Stent in Patients With Coronary Artery Disease (CAD)

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01182649
Acronym
RACES
Enrollment
600
Registered
2010-08-17
Start date
2007-03-31
Completion date
2010-06-30
Last updated
2010-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Atherosclerosis

Keywords

Drug Eluting Stents, Everolimus Eluting Stent, Coronary Angioplasty

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.

Interventions

coronary angioplasty with stent implantation

DEVICEstent

coronary angioplasty with stent implantation

Sponsors

San Giuseppe Moscati Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Target Vessel Revascularization2 yearIncidence of clinically driven target vessel revascularization at 2 year follow up

Secondary

MeasureTime frameDescription
cardiac death2 yearincidence of death for cardiac causes at 2 year
non fatal myocardial infarction2 yearincidence of non fatal Q or non Q wave reinfarction at 2 year
stent thrombosis2 yearincidence of definite, probable or possible stent thrombosis at 2 year

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026