Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial

Coronary Artery Disease Clinical Trial

— RESET  

Official title:

Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035450
• Other study ID #: C338
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2009
• Last updated: December 9, 2015
• Start date: February 2010
• Est. completion date: May 2014

Study information

• Verified date: December 2015
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice.

Description:

Sirolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Everolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in the first quarter of 2010 by the Japanese Ministry of Health, Labor and Welfare. It has recently been reported that everolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 1 year as compared with paclitaxel-eluting stent. However, trial results comparing everolimus-eluting stent with sirolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3206
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients scheduled for percutaneous coronary intervention using drug-eluting stents

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Everolimus-eluting stent
Everolimus-eluting stent
• Sirolimus-eluting stent
Sirolimus-eluting stent

Locations

Country	Name	City	State
Japan	Division of Cardiology, Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Takeshi Morimoto

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target-lesion revascularization		1-year	No
Primary	all-cause death or myocardial infarction		3-year	No
Secondary	all-cause death		3-year	No
Secondary	cardiac death		3-year	No
Secondary	myocardial infarction		3-year	No
Secondary	stent thrombosis (Academic Research Consortium definition)		3-year	No
Secondary	ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes		3-year	Yes
Secondary	bleeding complications (GUSTO and TIMI definition)		3-year	Yes
Secondary	stent deployment success		at implantation	No
Secondary	procedure time		at implantation	No
Secondary	clinically-driven target-lesion revascularization		3-year	No
Secondary	non-target-lesion revascularization		3-year	No
Secondary	coronary artery bypass grafting		3-year	No
Secondary	target-vessel revascularization		3-year	No
Secondary	any repeat coronary revascularization		3-year	No
Secondary	composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization		3-year	No
Secondary	composite of all-cause death, any myocardial infarction or any repeat coronary revascularization		3-year	No