Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Sten for Coronary Lesions in Acute Myocardial Infarction (EVERZOTA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Yonsei University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01347554
First received: April 27, 2011
Last updated: July 12, 2011
Last verified: February 2011
  Purpose

Most of the previous data regarding the efficacy of the everolimus-eluting stent (EES) was derived from studies comparing EES with bare metal stent (BMS) or EES with paclitaxel-eluting (PES). Although sirolimus-eluting stents (SES) have been shown to be the most efficacious drug regarding inhibition of neointima and late loss, there have been no previous head to head comparisons between EES and zotarolimus-eluting stent (ZES). Both everolimus and sirolimus are macrocyclic lactones that target the mTOR (mammalian target of rapamycin) to reduce vascular smooth muscle proliferation after vessel injury and therefore in principle may show similar results after stenting in humans. Data pooled from the EES arm that received follow up angiography in the SPIRIT III trial and the SES arm in the SIRIUS trial show similar rates of binary restenosis and late loss. However, the stent and polymer platform is not the same between the EES and ZES and it is reported that the EES system has the thinnest stent + polymer thickness (88.6um) of all of the previously KFDA-approved drug-eluting stent (DES). In addition, there are no data available on the efficacy of the EES and ZES in "real world" lesions other than the selected lesions studied in the previous trials, such as acute myocardial infarction.


Condition Intervention Phase
Myocardial Infarction
Device: Everolimus stent (Xience V)
Device: Zotarolimus stent (Endeavor resolute)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Stent for Coronary Lesions in Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, ischemia driven target lesion revascularization at 12 months. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Individual components of safety issue [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    All Death/Cardiac death

  • Individual components of safety issue [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Bleeding

  • Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Myocardial infarction (Q-wave and non-Q wave)

  • Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Target vessel revascularization (TVR)

  • Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Target lesion revascularization (TLR)

  • Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Stent thrombosis

  • Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Acute success

  • Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    In-segment late luminal loss (LL) at 9~12 months

  • Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    In-stent late loss at 9~12 months

  • Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Angiographic pattern of restenosis at 9~12 months angiographic follow-up

  • Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    In-stent and in-segment % diameter stenosis (%DS) at 9~12 months

  • Individual components of efficacy issue [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    MACE at 24 months


Enrollment: 500
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Xience V stent group
Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
Device: Everolimus stent (Xience V)
Everolimus eluting stent stenting
Other Name: Xience V
Active Comparator: Endeavor resolute group
Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
Device: Zotarolimus stent (Endeavor resolute)
Zotarolimus eluting stent stenting
Other Name: Endeavor resolute

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Chest pain duration more than 10 minutes
  • At least on of the following criteria
  • A. ECG change (T inversion, ST depression and ST elevation)
  • B. Cardiac enzyme elevation more than upper normal limit
  • Significant coronary artery stenosis (>50% by visual estimate)
  • The patient or guardian agrees to the study

Exclusion Criteria:

  • Stent thrombosis
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
  • Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months
  • An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment
  • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
  • Severe infective state
  • Patients with LVEF <25% or those with cardiogenic shock
  • Lt. main MI
  • Creatinine level more than 3.0mg/dL or dependence on dialysis
  • Severe hepatic dysfunction (AST and ALT 3 times upper normal limit)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347554

Locations
Korea, Republic of
Yonsei University Wonju College of Medicine; Wonju Christian Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Seung-Hwan Lee, MD, PhD Division of cardiology, Department of internal medicine, Wonju christian hospital, Yonsei University Wonju College of Medicine
  More Information

No publications provided

Responsible Party: Seung-Hwan Lee/Professor, Divison of cardiology, Department of internal medicine, Wonju Chrirstian Hospital
ClinicalTrials.gov Identifier: NCT01347554     History of Changes
Other Study ID Numbers: EVZT_1.0
Study First Received: April 27, 2011
Last Updated: July 12, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
drug-eluting stent
everolimus
zotarolimus
myocardial ischemia
cardiovascular diseases
MACE
safety

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 18, 2014