Contact information
Type
Scientific
Primary contact
Mr M.T. Dirksen
ORCID ID
Contact details
Onze Lieve Vrouwe Gasthuis
Oosterpark 9
Amsterdam
1090 HM
Netherlands
m.t.dirksen@olvg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PASSION
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
ST-segment elevation myocardial infarction (STEMI)
Intervention
Drug eluting stent (paclitaxel eluting stent) or conventional stent. Follow up planned for year 1, 2, 3, 5 and 10.
Intervention type
Drug
Phase
Not Specified
Drug names
Paclitaxel
Primary outcome measure
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 measures
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
Overall trial start date
28/03/2003
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
620, recruitment closed
Participant 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
Recruitment start date
28/03/2003
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Onze Lieve Vrouwe Gasthuis
Amsterdam
1090 HM
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Amsterdam Department of Interventional Cardiology (ADIC)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16971717
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21251625
Publication citations
-
Results
Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M, Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention., N. Engl. J. Med., 2006, 355, 11, 1105-1113, doi: 10.1056/NEJMoa062598.
-
Results
Vink MA, Dirksen MT, Suttorp MJ, Tijssen JG, van Etten J, Patterson MS, Slagboom T, Kiemeneij F, Laarman GJ, 5-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial., JACC Cardiovasc Interv, 2011, 4, 1, 24-29, doi: 10.1016/j.jcin.2010.11.003.