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

ISRCTN ISRCTN65027270
DOI https://doi.org/10.1186/ISRCTN65027270
Secondary identifying numbers N/A
Submission date
03/02/2006
Registration date
03/02/2006
Last edited
09/05/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr M.T. Dirksen
Scientific

Onze Lieve Vrouwe Gasthuis
Oosterpark 9
Amsterdam
1090 HM
Netherlands

Email m.t.dirksen@olvg.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymPASSION
Study objectivesThe 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) studiedST-segment elevation myocardial infarction (STEMI)
InterventionDrug eluting stent (paclitaxel eluting stent) or conventional stent. Follow up planned for year 1, 2, 3, 5 and 10.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Paclitaxel
Primary outcome measureThe 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 measures1. 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 study start date28/03/2003
Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants620, recruitment closed
Key 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
Key exclusion criteria1. 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 enrolment28/03/2003
Date of final enrolment01/01/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Onze Lieve Vrouwe Gasthuis
Amsterdam
1090 HM
Netherlands

Sponsor information

Amsterdam Department of Interventional Cardiology (ADIC) (The Netherlands)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/01d02sf11

Funders

Funder type

Hospital/treatment centre

Amsterdam Department of Interventional Cardiology (ADIC)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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