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Early Surgery Versus Conventional Treatment in Infective Endocarditis (EASE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00750373
First Posted: September 10, 2008
Last Update Posted: April 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duk-Hyun Kang, Asan Medical Center
Results First Submitted: June 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Endocarditis
Intervention: Procedure: Valve surgery with removal of vegetations

  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
Patients were eligible for enrollment if they were diagnosed as definite infective endocarditis and had both severe mitral or aortic valve disease and vegetation length > 10 mm. Between September 2006 and March 2011, a total of 76 patients were enrolled at the Asan Medical Center (n=71) and Seoul National University Hospital (n=5) in Korea.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The exclusion criteria were defined as patients with moderate to severe CHF; heart block; annular or aortic abscess; fungal endocarditis; and those who were not candidates for early surgery on the basis of age > 80 years, coexisting major embolic stroke with a risk of hemorrhagic transformation and/or poor medical status.

Reporting Groups
  Description
Conventional Conventional Treatment based on current guidelines
Surgery Early surgery within 48 hours of randomization

Participant Flow:   Overall Study
    Conventional   Surgery
STARTED   39   37 
COMPLETED   39   37 
NOT COMPLETED   0   0 



  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
Conventional Conventional Treatment based on current guidelines
Surgery Early surgery within 48 hours of randomization
Total Total of all reporting groups

Baseline Measures
   Conventional   Surgery   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   37   76 
Age 
[Units: Participants]
     
<=18 years   1   1   2 
Between 18 and 65 years   29   32   61 
>=65 years   9   4   13 
Age 
[Units: Years]
Mean (Standard Deviation)
 48  (17)   46  (15)   47  (16) 
Gender 
[Units: Participants]
     
Female   12   13   25 
Male   27   24   51 
Region of Enrollment 
[Units: Participants]
     
Korea, Republic of   39   37   76 


  Outcome Measures

1.  Primary:   Number of Participants With In-hospital Death or Clinical Embolic Events   [ Time Frame: within 6 weeks from the randomization ]

2.  Secondary:   All-cause Death   [ Time Frame: up to 6 month after enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Recurrences of Infective Endocarditis   [ Time Frame: up to 6 months after enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies   [ Time Frame: up to 6 months after enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Readmission Due to Development of Congestive Heart Failure   [ Time Frame: up to 6 months after enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
The EASE trial was a limited study in scope, in that it included patients with severe valvular disease and large vegetations, and excluded those with major stroke, prosthetic valve endocarditis or aortic abscess.


  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. Duk-Hyun Kang
Organization: Asan Medical Center
phone: 82-2-3010-3149
e-mail: dhkang@amc.seoul.kr


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

Responsible Party: Duk-Hyun Kang, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00750373     History of Changes
Other Study ID Numbers: 2006-0257
First Submitted: September 8, 2008
First Posted: September 10, 2008
Results First Submitted: June 29, 2012
Results First Posted: September 7, 2012
Last Update Posted: April 23, 2015