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

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ClinicalTrials.gov Identifier: NCT00426049
Recruitment Status : Unknown
Verified January 2007 by German Heart Institute.
Recruitment status was:  Recruiting
First Posted : January 24, 2007
Last Update Posted : January 24, 2007
Information provided by:
German Heart Institute

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Restenosis Drug: Everolimus Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Major adverse cardiac events (MACEs)within 6 months

Secondary Outcome Measures :
  1. MACEs within 30 days
  2. Quantitative angiographic observations within the vessel after 6 months
  3. TLR and TVR after 6 months
  4. Drug safety and tolerability for 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426049

Contact: Eckart Fleck, Professor +49-(0)30-4593 ext 2400 fleck@dhzb.de

German Heart Institute Berlin Recruiting
Berlin, Germany, 13353
Principal Investigator: Eckart Fleck, Professor         
Sponsors and Collaborators
German Heart Institute
Principal Investigator: Eckart Fleck, Professor German Heart Institute Berlin

ClinicalTrials.gov Identifier: NCT00426049     History of Changes
Other Study ID Numbers: CRAD001ADE07
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: January 24, 2007
Last Verified: January 2007

Keywords provided by German Heart Institute:
Coronary artery disease
Immunosuppressive Agents
Coronary restenosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents