No registrations found.
ID
Source
Brief title
Health condition
PATIENTS UNDERGOING PRIMARY PERCUTANEOUS INTERVENTION FOR ACUTE ST-SEGEMENT MYOCARDIAL INFARCTION.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
To determine the potential benefit of drug-eluting stents in the setting of ST-segment elevation myocardial infarction (STEMI) we will compare the clincial outcomes at 1 year in patients randomized to either drug eluting or conventional stent-implantation. This trial will determine whether the use of a drug eluting stent (paclitaxel eluting stent) in the setting of stemi is safe and improves clinical outcome at 1 year (as an indicator of re-stenosis) compared to conventional stent implantation. This is one of the first randomized, placebo controlled trial to evaluate the beneficial effects of a drug eluting stent in primary percutaneous coronary intervention for acute stemi conducted in a ‘real world’ study population.
Study objective
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.
Intervention
Drug eluting stent (paclitaxel eluting stent) or conventional stent.
Oosterpark 9
M.T. Dirksen
Oosterpark 9
Amsterdam 1090 HM
The Netherlands
m.t.dirksen@olvg.nl
Oosterpark 9
M.T. Dirksen
Oosterpark 9
Amsterdam 1090 HM
The Netherlands
m.t.dirksen@olvg.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL496 |
| NTR-old | NTR538 |
| Other | : N/A |
| ISRCTN | ISRCTN65027270 |