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

Completed

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

Registration Number: NL-OMON25456

Lead Sponsor: Amsterdam Department of Interventional Cardiology (ADIC)

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 620

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The secondary end points are:<br>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;<br>2. Occurence of stent thrombosis;<br>3. Success rate of primary PCI.