Trials / Unknown
UnknownNCT00426049
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 484 (planned)
- Sponsor
- German Heart Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Everolimus |
Timeline
- Start date
- 2006-10-01
- First posted
- 2007-01-24
- Last updated
- 2007-01-24
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00426049. Inclusion in this directory is not an endorsement.