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

San Giuseppe Moscati Hospital

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease; Coronary Atherosclerosis

Treatments: Device: coronary stent; Device: stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01182649

AOM_DES02

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

EES Group

Experimental group

Description:

Patients who received an everolimus eluting stent

Treatment:

Device: coronary stent

SES Gruop

Active Comparator group

Description:

Patients who received a sirolimus eluting stent

Treatment:

Device: stent