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EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events (EDUCATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01069003
First received: February 12, 2010
Last updated: December 11, 2015
Last verified: December 2015
Results First Received: June 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Drug: Placebo Arm
Drug: Thienopyridine Therapy
Device: Surveillance Arm

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled 2272 but only 2262 subjects were analysis receiving the Endeavor stent only.

Reporting Groups
  Description
Placebo

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).

Placebo (12-Month Arm): Placebo

ASA: 75 mg - 325 mg Aspirin(ASA)

Thienopyridine Therapy

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).

Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg

ASA: 75 mg - 325 mg Aspirin(ASA)

Surveillance Arm Non randomized subjects followed for total of 24 months

Participant Flow:   Overall Study
    Placebo   Thienopyridine Therapy   Surveillance Arm
STARTED   399   412   1451 
COMPLETED   353   358   976 
NOT COMPLETED   46   54   475 



  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.
The intent to treat arm contains non randomized subjects followed through 24 months

Reporting Groups
  Description
Placebo Arm

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).

Placebo (12-Month Arm): Placebo

ASA: 75 mg - 325 mg Aspirin(ASA)

Thienopyridine Therapy

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).

Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg

ASA: 75 mg - 325 mg Aspirin(ASA)

Surveillance Arm Non randomized subjects followed for total of 24 months
Total Total of all reporting groups

Baseline Measures
   Placebo Arm   Thienopyridine Therapy   Surveillance Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 399   412   1451   2262 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.8  (10.7)   62.5  (10.7)   64.6  (11.3)   63.3  (10.9) 
Gender 
[Units: Participants]
       
Female   122   116   449   687 
Male   277   296   1002   1575 
Region of Enrollment 
[Units: Participants]
       
United States   372   385   1409   2166 
Canada   27   27   42   96 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects   [ Time Frame: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) ]

2.  Primary:   Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects   [ Time Frame: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) ]

3.  Primary:   Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects   [ Time Frame: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) ]


  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
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  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: Sidney Cohen, Sr. Clinical Medical Advisor
Organization: Medtronic
phone: 707-591-7277
e-mail: sidney.a.cohen@medtonic.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01069003     History of Changes
Other Study ID Numbers: IP114
Study First Received: February 12, 2010
Results First Received: June 29, 2015
Last Updated: December 11, 2015
Health Authority: United States: Institutional Review Board