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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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Endeavor Resolute Stent Device: Xience V Stent Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Zotarolimus- and Everolimus-Eluting Stents for Coronary Treatment
Study Start Date : September 2008
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Endeavor Resolute Stent
Device: Endeavor Resolute Stent
Zotarolimus-eluting Endeavor Resolute Stent

Active Comparator: 2
Xience V Stent
Device: Xience V Stent
Everolimus-eluting Xience V Stent




Primary Outcome Measures :
  1. A composite of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation [ Time Frame: 1 year after randomization ]

Secondary Outcome Measures :
  1. Late luminal loss [ Time Frame: 6-8 months ]
  2. Binary angiographic restenosis [ Time Frame: 6-8 months ]
  3. All cause mortality [ Time Frame: 1 year ]
  4. Stent thrombosis [ Time Frame: 1 year ]


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

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.

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): NCT00768846


Contacts
Contact: Julinda Mehilli, MD +49-1218 ext 4582 mehilli@dhm.mhn.de
Contact: Stefanie Schulz, MD +49-1218 ext 1521 schulzs@dhm.mhn.de

Locations
Germany
1st Medizinische Klinik Klinikum rechts der Isar Recruiting
Munich, Germany, 81675
Contact: Josef Dirschinger, MD    +49-4140 ext 2947    dirschinger@med1.med.tum.de   
Deutsches Herzzentrum Munich Recruiting
Munich, Germany, 81675
Contact: Julinda Mehilli, MD    +49-1218- ext 4582    mehilli@dhm.mhn.de   
Contact: Stefanie Schulz, MD    +49-1218- ext 1521    schulzs@dhm.mhn.de   
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Munich
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Munich

Responsible Party: Prof. Dr. A. Schoemig, Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00768846     History of Changes
Other Study ID Numbers: GE IDE No. S03008
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: October 2008

Keywords provided by Deutsches Herzzentrum Muenchen:
PCI
Stent
DES
CAD

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