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ISRCTN
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ISRCTN65027270
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ClinicalTrials.gov identifier
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Public title
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Randomized comparison of paclitaxel eluting stent versus conventional stent in ST-segment elevation myocardial infarction
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Scientific title
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Acronym
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PASSION
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Serial number at source
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N/A
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Study hypothesis
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The use of a drug-eluting stent (DES), paclitaxel-eluting stent, in patients undergoing a primary percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction (STEMI) is safe and may effect short and long term clinical outcome.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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ST-segment elevation myocardial infarction (STEMI)
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Participants - inclusion criteria
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1. Acute myocardial infarction eligible for primary PCI: >20 min of chest-pain and at least 1 mm ST-elevation in two contiguous leads or a new left bundle branch block
2. Reperfusion expected to be feasible within 6 hours after onset of complaints
3. Stent eligible (coronary at least 2.5 mm) infarct related coronary artery
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Participants - exclusion criteria
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1. Age >18 and <80 years
2. Reperfusion not achievable within 6 hours of onset of complaints
3. Failed thrombolysis
4. Infarct related artery unsuitable for stent implantation
5. Sub-acute stent thrombosis
6. STEMI caused by in-stent re-stenosis
7. Infarct related vessel/target vessel bypass graft (SVG or LIMA)
8. Contraindication for aspirin and/or clopidogrel: intolerance, allergy
9. Participation in another clinical study, interfering with this protocol
10. Cardiogenic shock prior to randomization
11. Uncertain neurological outcome e.g. resuscitation
12. Intubation/ventilation
13. Known intracranial disease
14. Expected mortality from any cause within the next 6 months
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Anticipated start date
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28/03/2003
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Anticipated end date
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01/01/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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620, recruitment closed
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Interventions
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Drug eluting stent (paclitaxel eluting stent) or conventional stent. Follow up planned for year 1, 2, 3, 5 and 10.
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Primary outcome measure(s)
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The primary end point is the composite clinical endpoint of death of all causes, recurrent MI, target vessel revascularization (TVR) or target lesion (within 5 mm of stent edges) revascularization (TLR) at one year.
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Secondary outcome measure(s)
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1. The composite clinical endpoint of death of all causes, recurrent MI, target vessel revascularization (TVR) or target lesion (within 5 mm of stent edges) revascularization (TLR) at 6 months, 2 and 3 years
2. Occurence of stent thrombosis
3. Success rate of primary PCI
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Sources of funding
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Amsterdam Department of Interventional Cardiology (ADIC)
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Trial website
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Publications
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1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16971717
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21251625
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Contact name
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Mr
M.T.
Dirksen
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Address
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Onze Lieve Vrouwe Gasthuis
Oosterpark 9
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City/town
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Amsterdam
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Zip/Postcode
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1090 HM
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Country
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Netherlands
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Email
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m.t.dirksen@olvg.nl
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Sponsor
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Amsterdam Department of Interventional Cardiology (ADIC) (The Netherlands)
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Address
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Onze Lieve Vrouwe Gasthuis
P.O. Box 95500
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City/town
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Amsterdam
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Zip/Postcode
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1090 HM
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Country
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Netherlands
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Date applied
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03/02/2006
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Last edited
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09/05/2011
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Date ISRCTN assigned
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03/02/2006
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