coronary artery disease coronary intervention with bare metal stents
Conditions
Interventions
Product Name: Everolimus
Product Code: RAD001 A
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Deutsches Herzzentrum Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 (MACE) 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. ;Secondary Objective: Secondary objectives of this trial are to compare both treatment groups with respect to: • MACEs within 30 days • Quantitative angiographic and IVUS observations within the vessel • Clinical performance with regard to treatment success after 6 months • Need for target lesion revascularization (TLR) after 6 months • Need for target vessel revascularization (TVR) after 6 months • Rate of target vessel failure (TVF) • Drug safety and tolerability;Primary end point(s): Major adverse cardiac events (MACE) within 6 months including death, coronary artery bypass grafting (CABG) to the target vessel, Q-wave and non-Q-wave myocardial infarction, and target lesion revascularization. To compare both treatment groups related to: - MACE within 30 days - Quantitative angiographic observations - Clinical performance with regard to treatment success after 6 months - Need for target lesion revascularization (TLR) after 6 months - Need for target vessel revascularization (TVR) after 6 months - Rate of target vessel failure (TVF) - Drug safety and tolerability | — |
Countries
Germany
Outcome results
None listed