Acute coronary syndromes (unstable angina and non-ST segment elevation myocardial infarction) Circulatory System Angina pectoris
Conditions
Interventions
Early intervention:
Coronary angiography and intervention as soon as possible (within 24 hours of randomisation).
Delayed intervention:
Coronary angiog
Sponsors
Population Health Research Institute (PHRI) (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome (unstable angina or MI without persistent ST elevation), i.e. clinical history consistent with new onset, or a worsening pattern, of characteristic ischaemic chest pain or ischaemic symptoms occurring at rest or with minimal activity (lasting longer than five minutes or requiring sublingual nitroglycerin for relief of the pain) 2. Able to randomise within 24 hours of the onset of the most recent episode of symptoms 3. At least two of the three following additional criteria: 3.1. Age more than or equal to 60 years, either sex 3.2. Troponin T or I or creatine kinase - myocardial bands (CK-MB) above the upper limit of normal for the local institution 3.3. Electrocardiogram (ECG) changes compatible with ischaemia (i.e., ST depression at least 1 mm in two contiguous leads or T wave inversion mroe than 3 mm or any dynamic ST shift or transient ST elevation) 4. Written informed consent dated and signed
Exclusion criteria
Exclusion criteria: 1. Age less than 21 years 2. Not a suitable candidate for revascularisation 3. Co-morbid condition with life expectancy less than six months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first occurrence of the composite death/myocardial (re-)infarction/stroke up to day 180. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The composite of death, myocardial (re-)infarction, stroke, refractory ischaemia or repeat revascularisation at 180 days 2. The first occurrence of any component of the composite of death myocardial infarction and refractory ischaemia until day 14, 30, 90 and at six months (day 180) 3. Stroke at 30 days and 180 days 4. Need for mechanical or pharmacological coronary revascularisation (i.e., percutaneous coronary intervention [PCI], coronary artery bypass graft [CABG], thrombolysis) at days 30, 90 and 180 days | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Greece, India, Poland, Romania, Slovakia, Slovenia, Switzerland, United States of America
Contacts
Public ContactBrandi Meeks
Outcome results
None listed