Condition category
Circulatory System
Date applied
03/02/2006
Date assigned
03/02/2006
Last edited
09/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Amsterdam Department of Interventional Cardiology (ADIC) (The Netherlands)

Sponsor details

Onze Lieve Vrouwe Gasthuis
P.O. Box 95500
Amsterdam
1090 HM
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes