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…
ID
Bron
Verkorte titel
Aandoening
PATIENTS UNDERGOING PRIMARY PERCUTANEOUS INTERVENTION FOR ACUTE ST-SEGEMENT MYOCARDIAL INFARCTION.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
Drug eluting stent (paclitaxel eluting stent) or conventional stent.
Algemeen / deelnemers
Oosterpark 9
M.T. Dirksen
Oosterpark 9
Amsterdam 1090 HM
The Netherlands
m.t.dirksen@olvg.nl
Wetenschappers
Oosterpark 9
M.T. Dirksen
Oosterpark 9
Amsterdam 1090 HM
The Netherlands
m.t.dirksen@olvg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL496 |
| NTR-old | NTR538 |
| Ander register | : N/A |
| ISRCTN | ISRCTN65027270 |