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Early Discharge After Primary Percutaneous Coronary Intervention (EDAPPCI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acibadem University
ClinicalTrials.gov Identifier:
NCT01860079
First received: May 16, 2013
Last updated: March 9, 2016
Last verified: March 2016
Results First Received: December 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: ST Elevation Myocardial Infarction
Intervention: Procedure: early discharge

  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
The recruitment process began at May 2013 and finished May 2015. Acibadem University Medical Faculty, Mehmet Akif Ersoy Chest and Cardiovascular Surgery Training and Research Hospital, Dr.Siyami Ersek Chest and Cardiovascular Surgery Training and Research Hospital were the centers involved in the study.Nine-hundred subjects were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
131 patients were excluded due to unsuccesful PPCI, cardiogenic shock, signs of heart failure, stroke within a month, patients treated with thrombolytic agents for the index STEMI,chest pain recurrence, clinically significant arrhythmia >6 hours after PPCI, hypotension (<100 mmHg SBP) persisting after PPCI,inability to get informed consent.

Reporting Groups
  Description
Early Discharge Group In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
Standard Discharge Group Patients who stay longer (96-120 hours) as of a standard procedure.

Participant Flow:   Overall Study
    Early Discharge Group     Standard Discharge Group  
STARTED     384     385  
COMPLETED     370     363  
NOT COMPLETED     14     22  
Physician Decision                 14                 22  



  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.
Patients baseline characteristics

Reporting Groups
  Description
Early Discharge Group

In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.

early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.

Standard Discharge Group Patients who stay longer (96-120 hours) as of a standard procedure
Total Total of all reporting groups

Baseline Measures
    Early Discharge Group     Standard Discharge Group     Total  
Number of Participants  
[units: participants]
  370     363     733  
Age  
[units: years]
Mean (Standard Deviation)
  54.55  (10.25)     54.63  (11.82)     54.59  (11.05)  
Gender  
[units: participants]
     
Female     46     47     93  
Male     324     316     640  



  Outcome Measures

1.  Primary:   All Cause Mortality and Readmission at 30 Days.   [ Time Frame: 30 DAYS ]


  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 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: Prof.Dr.Şevket Görgülü
Organization: AcibademU
phone: +902623174444 ext 4123
e-mail: sevket5@yahoo.com


Publications:
O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX, Anderson JL, Jacobs AK, Halperin JL, Albert NM, Brindis RG, Creager MA, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Kushner FG, Ohman EM, Stevenson WG, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 Jan 29;127(4):e362-425. doi: 10.1161/CIR.0b013e3182742cf6. Epub 2012 Dec 17. Erratum in: Circulation. 2013 Dec 24;128(25):e481.


Responsible Party: Acibadem University
ClinicalTrials.gov Identifier: NCT01860079     History of Changes
Other Study ID Numbers: the EDAP PCI trial
Study First Received: May 16, 2013
Results First Received: December 17, 2015
Last Updated: March 9, 2016
Health Authority: Turkey: Ethics Committee