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Completed

NCT Number: NCT01860079

Early Discharge After Primary Percutaneous Coronary Intervention

* 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem University, Istanbul, Turkey (Türkiye)

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early discharge

Procedure

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Acronym: EDAPPCI

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 22, 2013
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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