Monocenter, double blinded, prospective, randomized, placebo controlled study investigating prevention of Major Adverse Cardiac Events (MACE) after 6 months by systemic treatment with Everolimus after coronary intervention with bare metal stents in patients with significant coronary artery disease - Restenosis-Study

• Conditions: coronary artery diseasecoronary intervention with bare metal stents

• Registration Number: EUCTR2005-002992-34-DE
• Lead Sponsor: Deutsches Herzzentrum Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-23
• Last Update Posted: 8 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Males or females, aged >/= 18 years
2. Patients with coronary artery disease and 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
6. Multiple lesions (up to three) may be treated if:
- each is less than or equal to 25 mm of length
- if they are located in different coronary arteries
- each lesion will be treated by one stent.
7. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
8. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Target lesion has a reference vessel size of less than 2.25 or more then 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 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
6. Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
7. Patients with thrombocytopenia (platelets < 75,000/mm³), with an absolute neutrophil count of < 1,500/mm³ or leucopenia (leucocytes < 2,500/mm³), or hemoglobin < 6 g/dl
8. Patients with symptoms of significant somatic or mental illness.
9. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent
10. Patients with a history of malignancy during the last five years, except squamous or basal cell carcinoma of the skin
11. Females of childbearing potential who are planning to become pregnant, who are pregnant or lactating, and/or who are unwilling to use effective means of contraception
12. Evidence of drug or alcohol abuse
13. Patients receiving drugs known to interact with Everolimus according to the list provided in Appendix 3 to this protocol.
14. Patients with any known hypersensitivity to Everolimus, other drugs similar to Everolimus (e.g., macrolides), Acetylsalicylic Acid (Aspirin®), Clopidogrel, Fluvastatin, or other components of the formulations (e.g. lactose)
15. Patients who have received an investigational drug within four weeks prior to study entry
16. Patients who have a history or pos. test result of HIV positive or Hepatitis B surface antigen positive or Hepatitis C virus positive.
17. Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified