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A Randomised Trial Comparing Same-Day Discharge with Overnight Hospital Stay after Elective Percutaneous Coronary Intervention: the Elective Percutaneous Coronary Intervention in Outpatient Study.


- candidate number1284
- NTR NumberNTR168
- ISRCTNISRCTN75891755
- Date ISRCTN created25-okt-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR30-aug-2005
- Secondary IDsN/A 
- Public TitleA Randomised Trial Comparing Same-Day Discharge with Overnight Hospital Stay after Elective Percutaneous Coronary Intervention: the Elective Percutaneous Coronary Intervention in Outpatient Study.
- Scientific TitleA Randomised Trial Comparing Same-Day Discharge with Overnight Hospital Stay after Elective Percutaneous Coronary Intervention: the Elective Percutaneous Coronary Intervention in Outpatient Study.
- ACRONYMEPOS
- hypothesisThe Elective PCI in Outpatient Study (EPOS) is designed to evaluate the safety and feasibility of discharge the same day as PCI, by testing the hypothesis that patients requiring extended observation can be selected effectively and that same-day discharge does not increase the complication rate as compared to overnight hospital stay.
- Healt Condition(s) or Problem(s) studiedAngina Pectoris
- Inclusion criteriaAll patients scheduled to undergo elective percutaneous coronary intervention in the Academic Medical Centre in Amsterdam who remain at home prior to the procedure.
- Exclusion criteria1. Scheduled use of guiding catheters larger than 6 French (F) in diameter;
2. Elective use of glycoprotein 2b/3a receptor blockers;
3. Long term systemic anti-coagulation;
4. Residence of more than 60 minutes drive from an intervention center;
5. No adult care person available at home for first 24 hours after PCI;
6. Diagnostic coronary artery catheterization with possible ad hoc PCI.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2000
- planned closingdate21-mrt-2003
- Target number of participants800
- InterventionsAfter percutaneous coronary intervention, patients are observed for 4 hours.
Patients randomized to same-day discharge are ambulated after this period and discharged. Patients randomized to overnight stay are discharged the following day. Indications for extended hospital stay are based on pre-defined clinical and angiographic criteria.
- Primary outcomeThe primary endpoint of the study is the composite of major adverse cardiac events and severe complications of the arterial puncture with the need of blood transfusion or repeat compression, from randomization until 24 hours after PCI.
- Secondary outcomeSecondary endpoints are the indication for extended observation, the occurrence of major adverse cardiac events and puncture site complications from randomization until 30 days after PCI, quality of life scores before and after PCI, actual costs related to PCI, aftercare and 30 days follow-up.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES G.S. Heyde
- CONTACT for SCIENTIFIC QUERIESDr. K.T. Koch
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Dutch Health Care Insurance Board (CVZ, independent governement organisation)
- PublicationsCirculation. 2007 May 1;115(17):2299-306. Epub 2007 Apr 9.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD23-aug-2005 - 4-jun-2008


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