Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation

Sponsor

German Heart Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT00426049

Collaborator

Novartis (Industry)

484

Enrollment

Location

Study Details

Study Description

Brief Summary

The purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in patients treated by bare metal stents for significant coronary artery disease. The aim is to reduce Major Adverse Cardiac Events (MACEs) including death, coronary artery bypass grafting (CABG) to the target vessel, Q-wave and non-Q-wave myocardial infarction, and target lesion revascularization within the first 6 months after intervention. Additionally safety and tolerability of Everolimus at the selected dose in this patient population will be analyzed.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Restenosis	Drug: Everolimus	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Monocenter, Double Blinded, Prospective, Randomized Placebo Controlled Study Investigating Prevention of Major Adverse Cardiac Events (MACEs) Within 6 Months by Systemic Treatment With Everolimus After Coronary Intervention With Bare Metal Stents in Patients With Significant Coronary Artery Disease

Study Start Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Major adverse cardiac events (MACEs)within 6 months []

Secondary Outcome Measures

MACEs within 30 days []
Quantitative angiographic observations within the vessel after 6 months []
TLR and TVR after 6 months []
Drug safety and tolerability for 6 months []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males or females, aged >18 years.
Patients with coronary artery disease who are scheduled for coronary intervention with bare metal stent placement for treatment of de novo or first restenosis in a native coronary artery.
Target lesion must be in a native coronary vessel of 2.25 - 4.0 mm size.
Target lesion has to be of less than or equal to 25 mm length.
Tandem lesion may be included as long as:

overall length is less than or equal to 25 mm
tandem lesion will be treated with one stent and counted as one lesion.

Exclusion Criteria:

The following exclusion criteria must not be present at Baseline visit 1 (BL1, Screening visit prior to coronary intervention). If an exclusion criterion occurred afterwards, e.g., during the coronary intervention, the patient must be excluded from the study.

Target lesion has a reference vessel size of less than 2.25 or more than 4.0 mm diameter.
Target lesion is a total occlusion or located at a bifurcation.
Treatment affords implantation of more than one stent per treated lesion.
Target lesion was already treated by brachytherapy.
Target lesion has one or more of the following criteria: