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

Paclitaxel eluting stent versus conventional stent in acute STE-myocardial infarction (PASSION) trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25456

Enrollment

620

Registered

2005-11-26

Start date

2003-03-28

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PATIENTS UNDERGOING PRIMARY PERCUTANEOUS INTERVENTION FOR ACUTE ST-SEGEMENT MYOCARDIAL INFARCTION.

Interventions

Drug eluting stent (paclitaxel eluting stent) or conventional stent.

Eligibility

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Age > 18 and < 80 years; 2. Reperfusion not achievable with 6 hrs after 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The secondary end points are: 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 year; 2. Occurence of stent thrombosis; 3. Success rate of primary PCI.	—

Contacts

Public ContactM.T. Dirksen

Onze Lieve Vrouwe Gasthuis (OLVG) Oosterpark 9

m.t.dirksen@olvg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)