Randomized comparison of paclitaxel eluting stent versus conventional stent in ST-segment elevation myocardial infarction
ISRCTN | ISRCTN65027270 |
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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
Scientific
Onze Lieve Vrouwe Gasthuis
Oosterpark 9
Amsterdam
1090 HM
Netherlands
m.t.dirksen@olvg.nl |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 28/03/2003 |
Completion date | 01/01/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 620, recruitment closed |
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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Onze Lieve Vrouwe Gasthuis
Amsterdam
1090 HM
Netherlands
1090 HM
Netherlands
Sponsor information
Amsterdam Department of Interventional Cardiology (ADIC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Onze Lieve Vrouwe Gasthuis
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |