NSTE-ACS
Conditions
Interventions
Patients admitted with NSTE-ACS who are eligible for PCI with stent implantation (as noted after angiography) will be randomised into one of the following treatment arms in this trial:
1. Immediate P
2. Early PCI (<48 hours after admission, but after 24 hours).
All patients will receive drug eluting stents and platelet IIb/IIIa blockers to at least 12 hours after PCI will be administered.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 21 years; 2. Typical chest pain for angina pectoris lasting at least 10 minutes, within last 6 hours; 3. No contra-indication to PCI; And at least one of the following criteria: 1. 1 mm of horizontal or downsloping ST depression; 2. Dynamic ST- or T- wave changes > 1 mm in two contiguous leads; 3. Elevated troponin or CK-Mb; 4. Known coronary artery disease; 5. Two of following risk factors: DM, known hypertension, current smoking, family hx, hypercholesterolaemia, peripheral artery disease, age over 60 years.
Exclusion criteria
Exclusion criteria: 1. Chest pain suspected not to be caused by CAD; 2. Acute myocardial infarction requiring reperfusion therapy; 3. Thrombolytic therapy 100 mmHg, systolic > 180 mmHg); 10. Life expectancy < 1 year due to co morbidity; 11. Known intracranial malformation or -neoplasm; 12. Participation in other study possibly interfering with the endpoints; 13. Inability to follow up; 14. Culprit lesion is a restenotic lesion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite incidence of death, MI and revascularization up to 30 days post enrolment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Size of MI during initial hospitalization, quantified as peak CK-MB (mass), cumulative positive CK-Mb's; 2. 6 month angiographic restenosis as a composite endpoint with, “large†MI and death; 3. Incidence of individual and composite endpoints at 30 days and 6 and 12 months including recurrent NSTE-ACS; 4. Any revascularisation and/or restenosis (TVR) up to 6 months; 5. Re-hospitalisation because of coronary artery disease (CAD); 6. Incidence of major haemorrhage up to 30 days; 7. Hospital costs. | — |
Contacts
Public ContactRobert K. Riezebos
Onze Lieve Vrouwe Gasthuis (OLVG), Research Cardiology, P.O. Box 95500
Outcome results
None listed