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

ISRCTN	ISRCTN65027270
DOI	https://doi.org/10.1186/ISRCTN65027270
Protocol serial number	N/A
Sponsor	Amsterdam Department of Interventional Cardiology (ADIC) (The Netherlands)
Funder	Amsterdam Department of Interventional Cardiology (ADIC)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr M.T. Dirksen
Scientific

Onze Lieve Vrouwe Gasthuis
Oosterpark 9
Amsterdam
1090 HM
Netherlands

Email	m.t.dirksen@olvg.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PASSION
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Paclitaxel
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.
Key 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
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	620
Key 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
Key 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
Date of first enrolment	28/03/2003
Date of final enrolment	01/01/2008

Onze Lieve Vrouwe Gasthuis

Amsterdam
1090 HM
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/09/2006		Yes	No
Results article	results	01/01/2011		Yes	No