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Randomized comparison of paclitaxel eluting stent versus conventional stent in ST-segment elevation myocardial infarction
ISRCTN ISRCTN65027270
DOI 10.1186/ISRCTN65027270
ClinicalTrials.gov identifier
EudraCT number
Public title Randomized comparison of paclitaxel eluting stent versus conventional stent in ST-segment elevation myocardial infarction
Scientific title
Acronym PASSION
Serial number at source N/A
Study hypothesis 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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain ST-segment elevation myocardial infarction (STEMI)
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 28/03/2003
Anticipated end date 01/01/2008
Status of trial Completed
Patient information material
Target number of participants 620, recruitment closed
Interventions Drug eluting stent (paclitaxel eluting stent) or conventional stent. Follow up planned for year 1, 2, 3, 5 and 10.
Primary outcome measure(s) 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.
Secondary outcome measure(s) 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
Sources of funding Amsterdam Department of Interventional Cardiology (ADIC)
Trial website
Publications 1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16971717
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21251625
Contact name Mr  M.T.  Dirksen
  Address Onze Lieve Vrouwe Gasthuis
Oosterpark 9
  City/town Amsterdam
  Zip/Postcode 1090 HM
  Country Netherlands
  Email m.t.dirksen@olvg.nl
Sponsor Amsterdam Department of Interventional Cardiology (ADIC) (The Netherlands)
  Address Onze Lieve Vrouwe Gasthuis
P.O. Box 95500
  City/town Amsterdam
  Zip/Postcode 1090 HM
  Country Netherlands
Date applied 03/02/2006
Last edited 09/05/2011
Date ISRCTN assigned 03/02/2006
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