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Randomized comparison of paclitaxel eluting stent versus conventional stent in ST-segment elevation myocardial infarction.


- candidate number1857
- NTR NumberNTR538
- ISRCTNISRCTN65027270
- Date ISRCTN created3-feb-2006
- date ISRCTN requested3-feb-2006
- Date Registered NTR26-nov-2005
- Secondary IDsN/A 
- Public TitleRandomized comparison of paclitaxel eluting stent versus conventional stent in ST-segment elevation myocardial infarction.
- Scientific TitlePaclitaxel eluting stent versus conventional stent in acute STE-myocardial infarction (PASSION) trial.
- ACRONYMPASSION
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedST-segment elevation myocardial infarction (STEMI), Myocardial infarction
- Inclusion criteria1. 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.
- Exclusion criteria1. Age > 18 and < 80 years; 2. Reperfusion not achievable with 6 hrs after 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 28-mrt-2003
- planned closingdate1-jan-2008
- Target number of participants620
- InterventionsDrug eluting stent (paclitaxel eluting stent) or conventional stent.
- Primary outcomeThe 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 outcomeThe secondary end points are: 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 year; 2. Occurence of stent thrombosis; 3. Success rate of primary PCI.
- Timepoints
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES M.T. Dirksen
- CONTACT for SCIENTIFIC QUERIES G.J. Laarman
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG), Department of Interventional Cardiology (ADIC)
- Funding
(Source(s) of Monetary or Material Support)
Amsterdam Department of Interventional Cardiology (ADIC)
- PublicationsN/A
- Brief summaryTo determine the potential benefit of drug-eluting stents in the setting of ST-segment elevation myocardial infarction (STEMI) we will compare the clincial outcomes at 1 year in patients randomized to either drug eluting or conventional stent-implantation. This trial will determine whether the use of a drug eluting stent (paclitaxel eluting stent) in the setting of stemi is safe and improves clinical outcome at 1 year (as an indicator of re-stenosis) compared to conventional stent implantation. This is one of the first randomized, placebo controlled trial to evaluate the beneficial effects of a drug eluting stent in primary percutaneous coronary intervention for acute stemi conducted in a ‘real world’ study population.
- Main changes (audit trail)
- RECORD26-nov-2005 - 6-mrt-2006


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