Acute Myocardial Infarction Circulatory System Acute Myocardial Infarction
Conditions
Interventions
1. Facilitated Percutaneous Coronary Intervention (PCI) strategy: Full-dose weight-adjusted tenecteplase + unfractionated heparin or Enoxaparin (30 mg IV bolus + 1 mg/kg subcutaneously [sc]), followed
Sponsors
University of Toronto (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1158 persons with acute myocardial infarction of both sex, 18 years and older. Patients greater than or equal to 18 years old who present within 12 hours of symptom onset with more than 30 minutes of continuous symptoms of an acute myocardial infarction, with high risk characteristics, defined as either: 1. 2 mm ST-segment elevation in 2 or more contiguous anterior leads 2. 1 mm ST-segment elevation in 2 or more contiguous inferior leads with either: 2.1. Systolic blood pressure less than 100 mmHg 2.2. Heart Rate greater than 100/minute 2.3. Killip Class II - III 2.4. 2 mm ST-segment depression in anterior leads 2.5. 1 mm ST-segment elevation in right-sided lead V4 (V4R), indicative of right ventricular involvement
Exclusion criteria
Exclusion criteria: 1. Left Bundle Branch Block 2. Cardiogenic Shock (Killip Class IV) 3. Active bleeding or known haemorrhagic diathesis 4. Availability of Primary PCI with door-to- balloon time = 60 minutes 5. Time from thrombolysis to initiation of consent process greater than 30 minutes 6. Use of thrombolytic agent other than tenecteplase for index event 7. Major surgery, biopsy of parenchymal organ, or significant trauma in the past 6 weeks 8. Systolic blood pressure greater than 200 mmHg or diastolic greater than 110 mmHg after arrival to the hospital and before enrolment 9. Concomitant use of oral anticoagulants (e.g. warfarin) with International Normalized Ratio (INR) of greater than 2 10. Recent non-compressible vascular puncture 11. History of central nervous system structural damage (e.g. aneurysm, neoplasm, arteriovenous malformation, stroke) at any time, or transient ischaemic attack within the last year 12. History of heparin-induced thrombocytopenia 13. Documented allergy to aspirin 14. Participation in other clinical research studies involving experimental therapies including drugs or devices within 7 days of enrolment or prior participation in this study 15. Inability to cooperate with the protocol or undergo cardiac catheterisation 16. Other serious illness (e.g. active cancer, significant hepatic or renal disease) 17. Percutaneous coronary intervention within the prior month 18. Previous bypass surgery 19. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day composite of: 1. Death (all cause) 2. Reinfarction 3. Recurrent ischaemia 4. New or Worsening Congestive Heart Failure, including readmission for heart failure 5. Development of cardiogenic shock requiring inotropic support or intra-aortic balloon pump insertion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The incidence of major/severe bleeding, as defined by the TIMI and GUSTO bleeding classifications in the first 30 days 2. The proportion of patients with complete (greater than 70%) and partial (30 - 70%) ST-segment resolution from the qualifying ECG to 6 hours after randomisation 3. Infarct size as assessed by QRS scoring system on the 180 minute 12-lead electrocardiogram 4. The composite of death or reinfarction at 6 months 5. The composite of death or reinfarction at 1 year 6. Health costs | — |
Countries
Canada
Outcome results
None listed