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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01347554
First received: April 27, 2011
Last updated: September 23, 2014
Last verified: September 2014
Results First Received: September 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myocardial Infarction
Interventions: Device: Everolimus eluting stent
Device: Zotarolimus eluting stent

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between January 2009 and December 2010, we undertook a multicenter, prospective, randomized trial in 4 tertiary university hospitals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with acute myocardial infarction were eligible if they had at least one lesion with a diameter stenosis of 50%or more. Before randomization, 3 patients withdrew consent and 18 patients did not meet inclusion criteria among 500 patients.

Reporting Groups
  Description
Xience V Stent Group Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
Endeavor Resolute Group Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction

Participant Flow:   Overall Study
    Xience V Stent Group     Endeavor Resolute Group  
STARTED     237     242  
COMPLETED     230 [1]   231 [2]
NOT COMPLETED     7     11  
Lack of Efficacy                 7                 11  
[1] Final TIMI flow grade 0 or 1 patients or failed PCI cases (N=7) were excluded.
[2] Final TIMI flow grade 0 or 1 patients or failed PCI cases (N=11) were excluded.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Xience V Stent Group Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
Endeavor Resolute Group Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
Total Total of all reporting groups

Baseline Measures
    Xience V Stent Group     Endeavor Resolute Group     Total  
Number of Participants  
[units: participants]
  230     231     461  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     106     106     212  
>=65 years     124     125     249  
Age  
[units: years]
Mean ± Standard Deviation
  64.5  ± 12.8     64.5  ± 11.8     64.5  ± 12.3  
Gender  
[units: participants]
     
Female     63     62     125  
Male     167     169     336  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     230     231     461  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Device-oriented Composite Outcome   [ Time Frame: Two year ]

2.  Secondary:   Device-oriented Composite Outcome   [ Time Frame: Two years ]

3.  Secondary:   Stent Thrombosis   [ Time Frame: Two years ]

4.  Secondary:   Any Bleeding   [ Time Frame: Two year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Relatively small number of sample size. Therefore, our result may be underpowerd. The incidence of clinical events were low. And we did not record the compliance of dual antiplatelet therapy for at least 1 year.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Seung-Hwan Lee
Organization: Yonsei University Wonju College of Medicine
phone: +82-33-741-0920
e-mail: carshlee@yonsei.ac.kr


No publications provided


Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01347554     History of Changes
Other Study ID Numbers: EVZT_2.0
Study First Received: April 27, 2011
Results First Received: September 23, 2014
Last Updated: September 23, 2014
Health Authority: Korea: Institutional Review Board