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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00426049
• Other study ID #: CRAD001ADE07
• Status: Recruiting
• Phase: Phase 3
• First received: January 23, 2007
• Last updated: January 23, 2007
• Start date: October 2006

Study information

• Verified date: January 2007
• Source: German Heart Institute
• Contact: Eckart Fleck, Professor
• Phone: +49-(0)30-4593
• Email: fleck[@]dhzb.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 484
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

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.

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.

Other protocol defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Drug:
• Everolimus

Locations

Country	Name	City	State
Germany	German Heart Institute Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
German Heart Institute	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events (MACEs)within 6 months
Secondary	MACEs within 30 days
Secondary	Quantitative angiographic observations within the vessel after 6 months
Secondary	TLR and TVR after 6 months
Secondary	Drug safety and tolerability for 6 months