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

NCT00426049 | Unknown Phase 3

• 1 other identifier: CRAD001ADE07
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

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

Keywords

Coronary artery disease; Stents; Immunosuppressive Agents; Coronary restenosis; Safety

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events (MACEs)within 6 months

Secondary Outcomes (4)

• 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

Interventions

Everolimus DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• German Heart Institute: lead
• Novartis: collaborator

Study Sites (1)

German Heart Institute Berlin

Berlin, State of Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Stenosis

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Eckart Fleck, Professor

  German Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eckart Fleck, Professor

CONTACT

+49-(0)30-4593; fleck@dhzb.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 23, 2007
• First Posted: January 24, 2007
• Study Start: October 1, 2006
• Last Updated: January 24, 2007

Record last verified: 2007-01

Locations

DE (1)