Everolimus Stent in Patients With Coronary Artery Disease (CAD)

Coronary Artery Disease Clinical Trial

— RACES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182649
• Other study ID #: AOM_DES02
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2010
• Last updated: August 16, 2010
• Start date: March 2007
• Est. completion date: June 2010

Study information

• Verified date: May 2010
• Source: San Giuseppe Moscati Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• coronary stent
coronary angioplasty with stent implantation
• stent
coronary angioplasty with stent implantation

Locations

Country	Name	City	State
Italy	Division of Cardiology Aorn Moscati	Avellino

Sponsors (1)

Lead Sponsor	Collaborator
San Giuseppe Moscati Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Caixeta A, Leon MB, Lansky AJ, Nikolsky E, Aoki J, Moses JW, Schofer J, Morice MC, Schampaert E, Kirtane AJ, Popma JJ, Parise H, Fahy M, Mehran R. 5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J Am Coll Cardiol. 2009 Sep 1;54(10):894-902. doi: 10.1016/j.jacc.2009.04.077. — View Citation

Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016. — View Citation

Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7. — View Citation

Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Vessel Revascularization	Incidence of clinically driven target vessel revascularization at 2 year follow up	2 year	No
Secondary	cardiac death	incidence of death for cardiac causes at 2 year	2 year	No
Secondary	non fatal myocardial infarction	incidence of non fatal Q or non Q wave reinfarction at 2 year	2 year	No
Secondary	stent thrombosis	incidence of definite, probable or possible stent thrombosis at 2 year	2 year	Yes