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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00426049

Enrollment

484

Registered

2007-01-24

Start date

2006-10-31

Completion date

Unknown

Last updated

2007-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Restenosis

Keywords

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

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.

Interventions

DRUGEverolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Major adverse cardiac events (MACEs)within 6 months	—

Secondary

Measure	Time frame
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	—

Countries

Germany

Contacts

Primary ContactEckart Fleck, Professor

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026