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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00426049
Other study ID # CRAD001ADE07
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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