Acute myocardial infarction (AMI) Circulatory System Acute myocardial infarction (AMI)
Conditions
Interventions
Tenecteplase (TNKase) plus percutaneous coronary intervention (PCI) versus Tenecteplase (TNKase) alone
Sponsors
University of Ottawa Heart Institute (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ischemic chest discomfort of =30 minutes duration 2. Aged 18 years and older, either sex 3. Onset of Chest Pain =6 hours prior to entry into the study and one of the following high risk criteria: 3.1. Anterior AMI with ST-segment elevation =2 mm in each of at least contiguous precordial leads (V1-V6) 3.2. Extensive nonanterior AMI on a standard 12 lead electrocardiogram (ECG) defined as: 3.2.1. Eight or more leads with =0.1 mV ST elevation or depression, or both; ST segment elevation of >1 mm (0.1 mV) must be present in two or more contiguous electrocardiographic leads 3.2.2. Sum of ST-segment elevation >20 mm measured 60 msec after the J-point 4. Killip 3 and either ST segment elevation of >1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old 5. Systolic blood pressure 1 mm (0.1mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old
Exclusion criteria
Exclusion criteria: 1. Low risk AMI defined as having the absence of high risk features defined above 2. Acute bleeding 3. History of stroke or central nervous system (CNS) damage 4. Major surgery or trauma within the past 3 months 5. Uncontrolled hypertension (SBP =200 mmHg and/or DBP =120 mmHg despite treatment) 6. Prolonged (>10 min) cardiopulmonary resuscitation 7. Inadequate vascular access 8. Previous coronary artery bypass graft (CABG) 9. PTCA within the last 6 months 10. Abciximab (ReoPro TM) or other GP IIb/IIIa antagonists within the preceding 7 days 11. Coagulation disorder (i.e. international normalized ratio (INR) >2.0, platelets 300 µmol/l 19. Sustained hypotension defined as SBP <90 mmHg or the need for intravenous (IV) inotropes and/or intraaortic balloon counter pulsation to support the blood pressure 20. Known severe contrast (dye) allergy 21. Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point will be the composite of the following clinical events: 1. Death 2. Recurrent myocardial infraction 3. Recurrent unstable ischemia 4. Stroke, measured at 6 months after the index AMI | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine if combined pharmacological and interventional strategy compared to pharmacological alone: 1. Decreases the frequency of the following individual clinical events: a. Death b. Recurrent myocardial infarction c. Recurrent unstable ischemia d. Stroke 2. Improves ST-segment elevation resolution, a surrogate marker of clinical efficacy 3. Decreases the need for subsequent revascularization (PTCA of the target vessel, PTCA of a non-target vessel, or CABG) 4. Decreases the frequency of recurrent unstable ischemia 5. Decreases the frequency of CHF and cardiogenic shock 6. Decreases the frequency of CHF at follow-up 7. Improves CCS angina class at follow-up 8. Is economically attractive 9. Influences subsequent quality of life 10. Is feasible in community hospitals without an on-site catheterization laboratory i.e. patients with large AMI who are initially treated with thrombolytic therapy can be transferred safely and in a timely fashion to a centre equipped with a catheterization laboratory for interventional therapy | — |
Countries
Canada
Outcome results
None listed