Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00476957
First received: May 21, 2007
Last updated: May 27, 2014
Last verified: May 2014
Results First Received: September 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Ischemic Heart Disease
Intervention: Device: 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
8709 patients were randomized from May 2007 until December 2008 in 196 participating hospitals in 36 countries across five continents.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
80 patients were excluded because there was no validly signed consent available during monitoring and 2 patients retracted their consent before the procedure, resulting in a total of 8709 patients randomised.

Reporting Groups
  Description
E-ZES

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Stent : Stent implantation

C-SES

Cordis Cypher® Sirolimus-eluting Coronary Stent

Stent : Stent implantation


Participant Flow:   Overall Study
    E-ZES     C-SES  
STARTED     4357     4352  
COMPLETED     4181     4159  
NOT COMPLETED     176     193  
Lost to Follow-up                 176                 193  



  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.
Intention to treat analysis has been used.

Reporting Groups
  Description
E-ZES

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Stent : Stent implantation

C-SES

Cordis Cypher® Sirolimus-eluting Coronary Stent

Stent : Stent implantation

Total Total of all reporting groups

Baseline Measures
    E-ZES     C-SES     Total  
Number of Participants  
[units: participants]
  4357     4352     8709  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2428     2468     4896  
>=65 years     1929     1884     3813  
Age  
[units: years]
Mean ± Standard Deviation
  62.3  ± 10.6     62.1  ± 10.7     62.2  ± 10.6  
Gender  
[units: participants]
     
Female     1017     1044     2061  
Male     3340     3308     6648  
Region of Enrollment  
[units: participants]
     
Europe     3180     3179     6359  
South Asia     623     622     1245  
North America     115     115     230  
South America     25     25     50  
Australia     207     207     414  
New Zealand     43     42     85  
Middle East     164     162     326  



  Outcome Measures
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1.  Primary:   To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation   [ Time Frame: 3 years ]

Measure Type Primary
Measure Title To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation
Measure Description Definite or probable stent thrombosis rate.
Time Frame 3 years  
Safety Issue Yes  

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
E-ZES

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Stent : Stent implantation

C-SES

Cordis Cypher® Sirolimus-eluting Coronary Stent

Stent : Stent implantation


Measured Values
    E-ZES     C-SES  
Number of Participants Analyzed  
[units: participants]
  4357     4352  
To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation  
[units: participants]
  61     75  

No statistical analysis provided for To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation



2.  Secondary:   Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions   [ Time Frame: 3 years ]

Measure Type Secondary
Measure Title Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions
Measure Description Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions
Time Frame 3 years  
Safety Issue Yes  

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
E-ZES

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Stent : Stent implantation

C-SES

Cordis Cypher® Sirolimus-eluting Coronary Stent

Stent : Stent implantation


Measured Values
    E-ZES     C-SES  
Number of Participants Analyzed  
[units: participants]
  4357     4352  
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions  
[units: participants]
   
Total death and large non-fatal myocardial infarct     225     255  
Total death and non-fatal myocardial infarctions     331     360  
Cardiac death and large non-fatal MI     157     174  
Cardiac death and non-fatal MI     265     282  
Target lesion revascularization     249     156  
Stroke     77     72  
Bleeding events     201     184  

No statistical analysis provided for Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions




  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Frank van Leeuwen, Director Clinical Research Coronary and Renal Denervation
Organization: Medtronic Bakken Research Center
phone: +31 43 3566622
e-mail: frank.van.leeuwen@medtronic.com


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00476957     History of Changes
Other Study ID Numbers: Version 1.0 - 12 April 2007
Study First Received: May 21, 2007
Results First Received: September 17, 2013
Last Updated: May 27, 2014
Health Authority: Argentina: Human Research Bioethics Committee
Australia: Human Research Ethics Committee
Austria: Ethikkommission
Belgium: Institutional Review Board
Brazil: National Committee of Ethics in Research
Canada: Canadian Institutes of Health Research
China: Ethics Committee
Finland: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Greece: Ethics Committee
Hong Kong: Ethics Committee
India: Institutional Review Board
Ireland: Medical Ethics Research Committee
Israel: Ethics Commission
Italy: Ethics Committee
Italy: Ministry of Health
Jordan: Ethical Committee
Netherlands: Medical Ethics Review Committee (METC)
New Zealand: Institutional Review Board
Norway:National Committee for Medical and Health Research Ethics
South Africa: National Health Research Ethics Council
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration