Early Discharge After Primary Percutaneous Coronary Intervention (EDAPPCI)

March 9, 2016 updated by: Acibadem University

Early Discharge After Primary Percutaneous Coronary Intervention: A Prospective Randomized Multi-center Trial (the EDAP PCI Trial)

  • When Primary percutaneous coronary intervention (PPCI) is performed expeditiously and at a high-volume centre, it is the optimal approach for ST elevation myocardial infarction (STEMI) . In contrast to the clarity of how to treat STEMI, there is no clear definition for when to discharge and which patient to discharge.
  • An early discharge strategy may be desired by all parties (financial health care provider, treating physician, nurse, patient, patient's relatives)involved in STEMI.
  • The main goal in our study is to test the hypothesis that an early discharge strategy within 48-56 hours in patients with successful PPCI is as safe as in those patients who stay longer (96-120 hours) as of a standard procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Primary percutaneous coronary intervention (PPCI) has become the optimal reperfusion strategy for ST elevation myocardial infarction (STEMI) when the procedure is performed expeditiously and at a high-volume centre.In contrast to the clarity of how to treat STEMI, there is no clear definition for when to discharge and which patient to discharge.
  • It is conceivable to discharge patients with successful PPCI as early as possible, because a hospital stay longer than needed may create undesirable outcomes in terms of hospital infections, psychosocial reasons, adequate mobilization and patient comfort. In many tertiary centres with a busy PPCI programme insufficient bed capacity is an ongoing concern and threatens the continuous acceptance of new cases of acute infarctions. In addition, it has been indicated that an early discharge policy may lead to a substantial cost saving.
  • Although much work has been done in developing and validating risk scores that identify low risk patients, data on the implementation of early discharge strategies have been quite limited There are 3 randomised trials investigating the possibility of early discharge after PPCI. However, certain limitations of these studies are preventing to implement an early discharge strategy in all-comers, particularly because of the underrepresentation of older patients in clinical trials. The verification of this policy is also needed in patients with multivessel disease. The first prospective randomized trial, the PAMI II,7 is partly obsolete as major changes have been made in PPCI with respect to devices and adjunctive medication. The other two randomized trials were single-center pilot studies with small number of patients.
  • Therefore, the above mentioned literature information warrants to test the reproducibility of safety endpoints in a large scale multicenter trial, prior to application of the early discharge strategy in clinical practice.

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Mehmet Akif Ersoy Education and Training Hospital
      • Istanbul, Turkey
        • Siyami Ersek Education and Training Hospital
      • İstanbul, Turkey
        • Acibadem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent and subsequent written agreement of a family member (confirming good social background)
  • Acute STEMI, defined as >30 minutes of continuous typical chest pain and ST-segment elevation ≥2 mm in two contiguous electrocardiography leads and /or left bundle branch block within 12 hours of symptom onset.
  • Haemodynamically stable Angiographically
  • Successful PPCI procedure (TIMI 2-3 flow and %<20 residual stenosis) and an uneventful 24 hour follow up period
  • Single epicardial artery to be treated
  • Telephone contact between the patient and PCI center after discharge is available 24 hours daily

Exclusion Criteria:

  • Inability to consent
  • Patients treated with thrombolytic agents for the index STEMI
  • Cardiogenic shock,
  • Stroke within a month,
  • Signs of heart failure (Killip II-IV)
  • Hypotension (<100 mmHg SBP) persisting after PPCI
  • Chest pain recurrence
  • Clinically significant arrhythmia (requiring treatment) occurring >6 hours after PPCI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early discharge group
In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
Procedure: early discharge
In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
No Intervention: Standard discharge group
Patients who stay longer (96-120 hours) as of a standard procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Cause Mortality and Readmission at 30 Days.
Time Frame: 30 DAYS
The primary end points were all cause mortality by 1 month and readmission due to reinfarction, unstable angina, arrhythmia, congestive heart failure, revascularization, stroke or major bleeding at 1 month.
30 DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Study Chair: Sevket Gorgulu, MD, Acıbadem University School of Medicine
  • Principal Investigator: Tugrul Norgaz, MD, Acıbadem University School of Medicine
  • Principal Investigator: Sinan Dagdelen, MD, Acıbadem University School of Medicine
  • Principal Investigator: Nevzat Uslu, MD, Mehmet Akif Ersoy Education and Training Hospital
  • Principal Investigator: Aydin Yildirim, MD, Siyami Ersek Educational and Training Hospital
  • Principal Investigator: Ali Buturak, MD,, Acıbadem University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • the EDAP PCI trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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