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

NCT ID: NCT00426049

Last Updated: 2007-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

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.

Conditions

Coronary Artery Disease; Coronary Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Everolimus

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males or females, aged >18 years.

2. 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.

3. Target lesion must be in a native coronary vessel of 2.25 - 4.0 mm size.

4. Target lesion has to be of less than or equal to 25 mm length.

5. 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

1. Target lesion has a reference vessel size of less than 2.25 or more than 4.0 mm diameter.

2. Target lesion is a total occlusion or located at a bifurcation.

3. Treatment affords implantation of more than one stent per treated lesion.

4. Target lesion was already treated by brachytherapy.

5. Target lesion has one or more of the following criteria:

• Left main lesion
• Ostial lesion of the RCA
• Located at less than 2 mm after the origin of the LAD or RCX.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

German Heart Institute

OTHER

Sponsor Role: lead

Principal Investigators

Eckart Fleck, Professor

Role: PRINCIPAL_INVESTIGATOR

German Heart Institute

Locations

German Heart Institute Berlin

Berlin, State of Berlin, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Eckart Fleck, Professor

Role: CONTACT

fleck@dhzb.de

+49-(0)30-4593 ext. 2400

Other Identifiers

CRAD001ADE07

Identifier Type: -

Identifier Source: org_study_id