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Zotarolimus and Everolimus-Eluting Stents ProsPectively Compared in Real World (ZEPPELIN)

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ClinicalTrials.gov Identifier: NCT00768846
Recruitment Status : Unknown
Verified October 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
First Posted : October 8, 2008
Last Update Posted : October 15, 2008
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen

Tracking Information
First Submitted Date  ICMJE October 6, 2008
First Posted Date  ICMJE October 8, 2008
Last Update Posted Date October 15, 2008
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2008)
A composite of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation [ Time Frame: 1 year after randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2008)
  • Late luminal loss [ Time Frame: 6-8 months ]
  • Binary angiographic restenosis [ Time Frame: 6-8 months ]
  • All cause mortality [ Time Frame: 1 year ]
  • Stent thrombosis [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zotarolimus and Everolimus-Eluting Stents ProsPectively Compared in Real World
Official Title  ICMJE Randomized Comparison of Zotarolimus- and Everolimus-Eluting Stents for Coronary Treatment
Brief Summary The zotarolimus-eluting Endeavor Resolute stent is not inferior to the everolimus- eluting Xience V stent platform regarding a composite of cardiac death, myocardial infarction or target lesion revascularisation in a real-world population.
Detailed Description The use of stents has become common practice in the percutaneous treatment of coronary artery disease. Restenosis affected 20-40% of de novo coronary lesions treated with bare metal stents. Drug-eluting stents (DES) have emerged as the most effective strategy for the prevention of restenosis. The first available DES were the Sirolimus-eluting Cypher and the Paclitaxel-eluting Taxus stent. Although their mid-term efficacy has been well-established, there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, as well as of delayed onset of restenosis or catch-up phenomenon with DES. Recent evidence demonstrates that there might be differences between various DES in terms of safety and efficacy. The differences might be related to the drug, polymer or stent design. Everolimus (SDZ-RAD) and zotarolimus (ABT-578) are new antiproliferative agents that share some common structural and biological properties with sirolimus ("limus-group"). Both drugs bind to the intracellular sirolimus receptor, FK 506-binding protein 12 (FKBP 12). The drug-FKBP12 complex inhibits cell cycle progression via inactivation of the mammalian target of Rapamycin (mTOR) thereby regulating vascular smooth muscle cell migration and proliferation. Preclinical studies showed improved endothelialization and limited chronic inflammation of the everolimus-eluting stent compared with previous drug-eluting stents. Moreover, first randomized clinical trials of everolimus-eluting stents have shown promising results regarding safety, feasibility and efficacy in the suppression of neointimal proliferation. Safety and efficacy of the zotarolimus-eluting Endeavor stent have been investigated in the Endeavor clinical program. In the Endeavor III and IV trials, the Endeavour stent proved inferior to the Cypher and Taxus stents regarding angiographic endpoints. However, rates of target vessel failure were similar in both groups. The Endeavor RESOLUTE stent platform uses a new polymer with potential improvements of drug release compared to the Endeavor stent. The RESOLUTE clinical trial is the first-in man, observational, uncontrolled, non-randomized study evaluating the Endeavor Resolute drug-eluting stent with the new polymer. The trial enrolled a total of 130 patients with native coronary artery lesions. There are no data available comparing the zotarolimus-eluting Endeavor Resolute stent with the everolimus-eluting Xience V stent. Thus the aim of this prospective, randomized study is to compare the efficacy and safety of these two "new generation" drug-eluting stent platforms in a real world population.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Device: Endeavor Resolute Stent
    Zotarolimus-eluting Endeavor Resolute Stent
  • Device: Xience V Stent
    Everolimus-eluting Xience V Stent
Study Arms  ICMJE
  • Active Comparator: 1
    Endeavor Resolute Stent
    Intervention: Device: Endeavor Resolute Stent
  • Active Comparator: 2
    Xience V Stent
    Intervention: Device: Xience V Stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 6, 2008)
2600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients older than 18 years with symptomatic coronary artery disease undergoing PCI with stent implantation.
  • Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

  • Cardiogenic shock.
  • Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
  • Known allergy to the study medications: everolimus, zotarolimus, cobalt chrome.
  • Inability to take clopidogrel for at least 6 months.
  • Pregnancy (present, suspected or planned) or positive pregnancy test. (In women with childbearing potential a pregnancy test is mandatory.)
  • Previous enrollment in this trial.
  • Patient's inability to fully cooperate with the study protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00768846
Other Study ID Numbers  ICMJE GE IDE No. S03008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. A. Schoemig, Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Muenchen
Study Sponsor  ICMJE Deutsches Herzzentrum Muenchen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Munich
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Munich
PRS Account Deutsches Herzzentrum Muenchen
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP