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Trial record 1 of 1 for:    NCT00476957
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Randomized Study Comparing Endeavor With Cypher Stents (PROTECT) (PROTECT)

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ClinicalTrials.gov Identifier: NCT00476957
Recruitment Status : Completed
First Posted : May 22, 2007
Results First Posted : March 17, 2014
Last Update Posted : November 10, 2014
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Ischemic Heart Disease
Intervention Device: Stent
Enrollment 8709
Recruitment Details 8709 patients were randomized from May 2007 until December 2008 in 196 participating hospitals in 36 countries across five continents.
Pre-assignment Details 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.
Arm/Group Title E-ZES C-SES
Hide Arm/Group Description

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Stent : Stent implantation

Cordis Cypher® Sirolimus-eluting Coronary Stent

Stent : Stent implantation

Period Title: Overall Study
Started 4357 4352
Completed 4181 4159
Not Completed 176 193
Reason Not Completed
Lost to Follow-up             176             193
Arm/Group Title E-ZES C-SES Total
Hide Arm/Group Description

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Stent : Stent implantation

Cordis Cypher® Sirolimus-eluting Coronary Stent

Stent : Stent implantation

Total of all reporting groups
Overall Number of Baseline Participants 4357 4352 8709
Hide Baseline Analysis Population Description
Intention to treat analysis has been used.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4357 participants 4352 participants 8709 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2428
  55.7%
2468
  56.7%
4896
  56.2%
>=65 years
1929
  44.3%
1884
  43.3%
3813
  43.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4357 participants 4352 participants 8709 participants
62.3  (10.6) 62.1  (10.7) 62.2  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4357 participants 4352 participants 8709 participants
Female
1017
  23.3%
1044
  24.0%
2061
  23.7%
Male
3340
  76.7%
3308
  76.0%
6648
  76.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4357 participants 4352 participants 8709 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
1.Primary Outcome
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
Hide Description Definite or probable stent thrombosis rate.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title E-ZES C-SES
Hide Arm/Group Description:

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Stent : Stent implantation

Cordis Cypher® Sirolimus-eluting Coronary Stent

Stent : Stent implantation

Overall Number of Participants Analyzed 4357 4352
Measure Type: Number
Unit of Measure: participants
61 75
2.Secondary Outcome
Title Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title E-ZES C-SES
Hide Arm/Group Description:

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Stent : Stent implantation

Cordis Cypher® Sirolimus-eluting Coronary Stent

Stent : Stent implantation

Overall Number of Participants Analyzed 4357 4352
Measure Type: Number
Unit of Measure: 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
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title E-ZES C-SES
Hide Arm/Group Description

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Stent : Stent implantation

Cordis Cypher® Sirolimus-eluting Coronary Stent

Stent : Stent implantation

All-Cause Mortality
E-ZES C-SES
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
E-ZES C-SES
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   579/4357 (13.29%)      507/4352 (11.65%)    
Cardiac disorders     
MACCE (major adverse cardiac and cerebrovascular event   579/4357 (13.29%)  579 507/4352 (11.65%)  507
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.6%
E-ZES C-SES
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   201/4357 (4.61%)      184/4352 (4.23%)    
Blood and lymphatic system disorders     
Bleeding   201/4357 (4.61%)  201 184/4352 (4.23%)  184
Indicates events were collected by systematic assessment
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.
For any publication or presentation of the Protected Materials or any portion thereof, a manuscript of the paper, abstract or other materials will be provided by Consultant to Sponsor for its approval at least sixty (60) days for manuscripts and thirty (30) days for presentations prior to outside submission. Medtronic shall have the right to request reasonable modifications of any manuscript or other materials to be published or presented.
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00476957     History of Changes
Other Study ID Numbers: Version 1.0 - 12 April 2007
First Submitted: May 21, 2007
First Posted: May 22, 2007
Results First Submitted: September 17, 2013
Results First Posted: March 17, 2014
Last Update Posted: November 10, 2014