 International, multicenter, randomized, double-blind, phase III trial
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ASSENT-2: Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators. Single bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomized trial. Lancet. 1999;354:716-722.
Objective
Double-blind, randomized, controlled Phase III trial to compare the efficacy and safety of accelerated infusion of Activase and single bolus TNKase dosed according to estimated or actual weight if available.
Primary Endpoint and Results
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All-cause mortality at 30 days
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| > |
6.2% for TNKase (N=8461), 6.2% for Activase (N=8488)
(relative risk 1.00; 95% CI = 0.89–1.12) |
Secondary Endpoints and Results
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Intracranial hemorrhage (ICH) at 30 days
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| > |
0.9% for TNKase (N=8461), 0.9% for Activase (N=8488) (relative risk 0.99; 95% CI = 0.73–1.35)
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Any stroke at 30 days
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| > |
1.8% for TNKase, 1.7% for Activase (relative risk 1.07; 95% CI = 0.86–1.35)
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Death or non-fatal stroke at 30 days
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| > |
7.1% for TNKase, 7.0% for Activase (relative risk 1.01; 95% CI = 0.91–1.13)
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Major non-cerebral bleeding events
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| > |
Reduced rate of major non-cerebral bleeding*—4.7% for TNKase, 5.9% for Activase (p=0.0002, relative risk 0.78; 95% CI = 0.69–0.89)
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| > |
Trend toward reduced rate of minor non-cerebral bleeding—21.8% for TNKase, 23.0% for Activase (p=0.0553; relative risk 0.94; 95% CI = 0.89–1.00)
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| > |
Reduced need for blood transfusions—4.3% for TNKase, 5.5% for Activase (p=0.0002; relative risk 0.77; 95% CI = 0.67–0.89) |
* |
Major bleeding is defined as bleeding requiring blood transfusion or leading to hemodynamic compromise. |
Indication: For use in mortality reduction associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.
Safety Information: TNKase therapy is contraindicated in the following conditions due to an increased risk of bleeding: active internal bleeding, history of cerebrovascular accident, intracranial or intraspinal surgery or trauma within 2 months, intracranial neoplasm, arteriovenous malformation, or aneurysm, known bleeding diathesis, and severe uncontrolled hypertension.
All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in eligible patients. In addition, thrombolytic therapy increases the risk of stroke, including hemorrhagic stroke, particularly in elderly patients. In patients with large ST segment elevation myocardial infarction, physicians should choose either thrombolysis or percutaneous coronary intervention (PCI) as the primary treatment strategy for reperfusion. Rescue PCI or subsequent elective PCI may be performed after administration of thrombolytic therapies if medically appropriate.
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