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Early Surgery Versus Conventional Treatment in Infective Endocarditis (EASE)

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ClinicalTrials.gov Identifier: NCT00750373
Recruitment Status : Completed
First Posted : September 10, 2008
Results First Posted : September 7, 2012
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
Duk-Hyun Kang, Asan Medical Center

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
Enrollment 76

Recruitment Details 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 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.
Arm/Group Title Conventional Surgery
Hide Arm/Group Description Conventional Treatment based on current guidelines Early surgery within 48 hours of randomization
Period Title: Overall Study
Started 39 37
Completed 39 37
Not Completed 0 0
Arm/Group Title Conventional Surgery Total
Hide Arm/Group Description Conventional Treatment based on current guidelines Early surgery within 48 hours of randomization Total of all reporting groups
Overall Number of Baseline Participants 39 37 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 37 participants 76 participants
<=18 years
1
   2.6%
1
   2.7%
2
   2.6%
Between 18 and 65 years
29
  74.4%
32
  86.5%
61
  80.3%
>=65 years
9
  23.1%
4
  10.8%
13
  17.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 37 participants 76 participants
48  (17) 46  (15) 47  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 37 participants 76 participants
Female
12
  30.8%
13
  35.1%
25
  32.9%
Male
27
  69.2%
24
  64.9%
51
  67.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 39 participants 37 participants 76 participants
39 37 76
1.Primary Outcome
Title Number of Participants With In-hospital Death or Clinical Embolic Events
Hide Description The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.
Time Frame within 6 weeks from the randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intention to treat analysis
Arm/Group Title Conventional Surgery
Hide Arm/Group Description:
Conventional Treatment based on current guidelines
Early surgery within 48 hours of randomization
Overall Number of Participants Analyzed 39 37
Measure Type: Number
Unit of Measure: participants
9 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional, Surgery
Comments We estimated that a sample size of 74 patients would provide 80% power to detect a significant difference with respect to the primary end point at the 2-sided significance level of 0.05, assuming that the in-hospital event rate would be 23% in the conventional treatment group and 3% in the early surgery group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title All-cause Death
Hide Description [Not Specified]
Time Frame up to 6 month after enrollment
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Recurrences of Infective Endocarditis
Hide Description [Not Specified]
Time Frame up to 6 months after enrollment
Outcome Measure Data Not Reported
4.Secondary Outcome
Title All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies
Hide Description [Not Specified]
Time Frame up to 6 months after enrollment
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Readmission Due to Development of Congestive Heart Failure
Hide Description [Not Specified]
Time Frame up to 6 months after enrollment
Outcome Measure Data Not Reported
Time Frame All patients underwent complete follow-up that began in September 2006 and ended in September 2011.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conventional Surgery
Hide Arm/Group Description Conventional Treatment based on current guidelines Early surgery within 48 hours of randomization
All-Cause Mortality
Conventional Surgery
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Surgery
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/39 (23.08%)      1/37 (2.70%)    
Cardiac disorders     
Cardiac death   2/39 (5.13%)  2 0/37 (0.00%)  0
Infections and infestations     
In-hospital noncardiac death   0/39 (0.00%)  0 1/37 (2.70%)  1
Vascular disorders     
embolism   8/39 (20.51%)  8 0/37 (0.00%)  0
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 0%
Conventional Surgery
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/39 (2.56%)      0/37 (0.00%)    
Infections and infestations     
recurrence of infective endocarditis   1/39 (2.56%)  1 0/37 (0.00%)  0
Indicates events were collected by systematic assessment
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.
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
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