Status:
COMPLETED
Routine Angioplasty and Stenting After Fibrinolysis for Acute Myocardial Infarction
Lead Sponsor:
Canadian Heart Research Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Hoffmann-La Roche
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: In Canada, most patients with acute myocardial infarction (AMI) present to hospitals without cardiac catheterization facilities. Thrombolytic therapy remains the standard-of-care in these...
Detailed Description
Patients with ST-elevation myocardial infarction and high-risk characteristics presenting to community hospitals without cardiac catheterization facilities will receive thrombolysis with tenecteplase ...
Eligibility Criteria
Inclusion
- 1\. Patients \>= 18 years old who present within 12 hours of symptom onset with more than 30 minutes of continuous symptoms of an acute myocardial infarction to a centre that does not perform primary PCI, with either:
- \>= 2 mm ST-segment elevation in 2 or more contiguous anterior leads
- \>= 1 mm ST-segment elevation in 2 or more contiguous inferior leads with at least one of the following high-risk features:
- Systolic blood pressure \< 100 mm Hg
- Heart rate \> 100/minute
- Killip Class II-III
- \>= 2 mm ST-segment depression in anterior leads
- \>= 1 mm ST-segment elevation in right-sided lead V4 (V4R), indicative of right ventricular involvement
Exclusion
- Left bundle branch block
- Cardiogenic shock (Killip Class IV requiring vasopressors or inotropic support to maintain a systolic blood pressure \> 90) prior to randomization
- Active bleeding or known hemorrhagic diathesis
- Availability of primary PCI with door-to-balloon time ≤ 60 minutes
- Time from thrombolysis to initiation of consent process \> 30 minutes
- Use of thrombolytic agent other than tenecteplase (TNK) for index event
- Major surgery, biopsy of parenchymal organ, or significant trauma in the past 6 weeks
- Systolic blood pressure \> 200 mm Hg or diastolic \> 110 mm Hg after arrival to the hospital and before enrollment
- Concomitant use of oral anticoagulants (e.g. warfarin) with International Normalized Ratio (INR) of \> 2
- Recent non-compressible vascular puncture
- History of central nervous system structural damage (e.g. aneurysm, neoplasm, arteriovenous malformation, stroke) at any time, or transient ischemic attack within the last year
- History of heparin-induced thrombocytopenia
- Documented allergy to aspirin
- Participation in other clinical research studies involving experimental therapies including drugs or devices within 7 days of enrollment or prior participation in this study
- Inability to cooperate with the protocol or undergo cardiac catheterization
- Other serious illness (e.g. active cancer, significant hepatic disease)
- Serum creatinine \> 140 umol/L
- Percutaneous coronary intervention within one month
- Previous bypass surgery
- Pregnancy
- Use of enoxaparin (or other low molecular weight heparin) in last 12 hours in patient \> 75 years of age
- Inferior ST-elevation myocardial infarction with none of the 5 high-risk features listed in the inclusion criteria
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00164190
Start Date
July 1 2004
End Date
January 1 2009
Last Update
October 18 2010
Active Locations (1)
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1
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2R2