Alteplase

(Activase®)

Activase®

Drug updated on 11/1/2024

Dosage FormInjection (intravenous; 50 mg, 100 mg)
Drug ClassTissue plasminogen activators
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of Acute Ischemic Stroke (AIS)
  • Indicated for the treatment of Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure
  • Indicated for the treatment of Acute Massive Pulmonary Embolism (PE) for lysis.

Latest News

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Summary
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  • This summary is based on the review of 42 systematic review(s)/meta-analysis(es). [1-42]
  • Excellent Functional Outcome (mRS 0-1 at 3 months): Tenecteplase was associated with higher likelihoods of achieving excellent functional outcomes compared to alteplase, with some studies showing significant differences (RR (relative risk) = 1.05, 95% CI (confidence interval): 1.01-1.10, p=0.012) and (OR (odds ratio) = 1.15, 95% CI: 1.01-1.32), although others reported no significant difference (OR = 1.08, 95% CI: 0.93-1.26) and (OR = 1.10, 95% CI: 0.98-1.23).
  • Good Functional Outcome (mRS 0-2 at 3 months): Similar good functional outcomes were reported between tenecteplase and alteplase in several studies (RR = 1.03, 95% CI: 0.99-1.07), with some reports indicating tenecteplase’s superiority over placebo but comparability to alteplase (OR = 1.54, 95% CI: 1.19-1.98).
  • Early Neurological Improvement: Tenecteplase showed a higher rate of early neurological improvement, with significant early recanalization (OR = 2.02, 95% CI: 1.20-3.38) and enhanced early neurological recovery (OR = 1.53, 95% CI: 1.03-2.26).
  • Tenecteplase was associated with significantly higher rates of early vessel recanalization compared to alteplase (OR = 2.07, 95% CI: 1.19-3.59), with particularly improved outcomes in Asian patients.
  • Symptomatic Intracranial Hemorrhage (sICH): The incidence of sICH was similar between tenecteplase and alteplase across multiple studies, including reports with RR = 1.12, 95% CI 0.83-1.53; OR = 1.12, 95% CI 0.79-1.59; OR = 1.06, 95% CI 0.70-1.60.
  • Mortality: Three-month mortality rates were comparable between tenecteplase and alteplase (RR = 0.97, 95% CI 0.82-1.15 and OR = 0.99, 95% CI 0.83-1.19), though moderate certainty evidence suggested that tenecteplase may reduce all-cause mortality (aOR = 0.44, 95% CI 0.30-0.64).
  • Tenecteplase demonstrated higher rates of complete recanalization in Asian patients compared to Caucasian patients, though Asian patients also experienced higher mortality rates. In patients older than 80 years, tenecteplase at a 0.25 mg/kg dose was associated with improved 90-day modified Rankin Scale scores and reduced mortality relative to alteplase, with no observed differences among younger patients.

Product Monograph / Prescribing Information

Document TitleYearSource
Activase (alteplase) Prescribing Information.2022Genentech, Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Tenecteplase vs Alteplase in Acute Ischemic Stroke Within 4.5 Hours: A Systematic Review and Meta-Analysis of Randomized Trials2024Neurology
Ethnic Differences in the Safety and Efficacy of Tenecteplase Versus Alteplase for Acute Ischemic Stroke: A Systematic Review and Meta-Analysis2024Journal of Stroke
Comparative efficacy and safety among different doses of tenecteplase for acute ischemic stroke: A systematic review and network meta-analysis2024Journal of Stroke and Cerebrovascular Diseases : the Official Journal of National
Efficacy and safety of intravenous tenecteplase compared to alteplase before mechanical thrombectomy in acute ischemic stroke: a meta-analysis2024Journal of Neurology
Tenecteplase versus Alteplase in Acute Ischemic Stroke: A Systematic Review and Meta-analysis2024Annals of Neurosciences
Intravenous alteplase in minor nondisabling ischemic stroke: A systematic review and meta-analysis2024European Stroke Journal
Tenecteplase versus alteplase for the treatment of acute ischemic stroke: a meta-analysis of randomized controlled trials2024Annals of Medicine
Tenecteplase versus alteplase for acute ischemic stroke: a systematic review and meta-analysis of randomized and non-randomized studies2024Journal of Neurology
Can the combination of antiplatelet or alteplase thrombolytic therapy with argatroban benefit patients suffering from acute stroke? a systematic review, meta-analysis, and meta-regression2024Plos One
Endovascular thrombectomy without versus with different pre-intravenous thrombolysis in acute ischemic stroke: a network meta-analysis of randomized controlled trials2024Frontiers in Neurology
Efficacy and safety outcomes of Tenecteplase versus Alteplase for thrombolysis of acute ischemic stroke: A meta-analysis of 9 randomized controlled trials2024Journal of the Neurological Sciences
Low-Dose Versus Standard-Dose Alteplase in Bridging Therapy for Large Vessel Stroke: A Systematic Review and Meta-Analysis2024Cerebrovascular Diseases (basel, Switzerland)
Intravenous thrombolysis with tenecteplase versus alteplase combined with endovascular treatment of anterior circulation tandem occlusions: A pooled analysis of ETIS and TETRIS2024European Stroke Journal
Tenecteplase versus alteplase for acute ischaemic stroke: a meta-analysis of phase III randomised trials2024Stroke and Vascular Neurology
Risk prediction models for intracranial hemorrhage in acute ischemic stroke patients receiving intravenous alteplase treatment: a systematic review2023Frontiers in Neurology
Tenecteplase versus alteplase for patients with acute ischemic stroke: a meta-analysis of randomized controlled trials2023Aging
Tenecteplase, 0.4 mg/kg, in Moderate and Severe Acute Ischemic Stroke: A Pooled Analysis of NOR-TEST and NOR-TEST 2A2023Journal of the American Heart Association
Tenecteplase vs. Alteplase for Intravenous Thrombolytic Therapy of Acute Ischemic Stroke: A Systematic Review and Meta-Analysis2023Neurology and Therapy
Different doses of tenecteplase vs. alteplase for acute ischemic stroke within 4.5 hours of symptom onset: a network meta-analysis of randomized controlled trials2023Frontiers in Neurology
The efficacy and safety of intravenous thrombolysis with tenecteplase versus alteplase for acute ischemic stroke: a systematic review and meta-analysis2023Neurological Sciences : Official Journal of the Italian Neurological Society and
Different dosing regimens of Tenecteplase in acute ischemic stroke: A network meta-analysis of the clinical evidence2023European Stroke Journal
Complications of Intravenous Tenecteplase Versus Alteplase for the Treatment of Acute Ischemic Stroke: A Systematic Review and Meta-Analysis2023Stroke
Safety and Efficacy of Tenecteplase and Alteplase in Patients With Tandem Lesion Stroke: A Post Hoc Analysis of the EXTEND-IA TNK Trials2023Neurology
Tenecteplase vs. alteplase for treatment of acute ischemic stroke: A systematic review and meta-analysis of randomized trials2023Frontiers in Neurology
Comparative efficacy and safety of tenecteplase and alteplase in acute ischemic stroke: A pairwise and network meta-analysis of randomized controlled trials2023Journal of the Neurological Sciences
The efficacy and safety of tenecteplase versus alteplase for acute ischemic stroke: an updated systematic review, pairwise, and network meta-analysis of randomized controlled trials2023Journal of Thrombosis and Thrombolysis
Short-Term Efficacy Outcomes of Tenecteplase versus Alteplase for Acute Ischemic Stroke: A Meta-Analysis of 5 Randomized Trials2022Neurology India
IV tPA for acute ischemic stroke in the setting of intracranial tumor: A scoping review2022Journal of Stroke and Cerebrovascular Diseases : the Official Journal of National
Safety and outcomes of thrombolytic therapy in patients with pulmonary embolism and thrombocytopenia: A systematic review2022Qatar Medical Journal
Catheter-directed therapies for the treatment of high risk (massive) and intermediate risk (submassive) acute pulmonary embolism2022The Cochrane Database of Systematic Reviews
The Efficacy and Safety of Ischemic Stroke Therapies: An Umbrella Review2022Frontiers in Pharmacology
Endovascular thrombectomy with or without intravenous alteplase for acute ischemic stroke due to large vessel occlusion: a systematic review and meta-analysis of randomized trials2022Stroke and Vascular Neurology
Safety and Efficacy of Tenecteplase in Older Patients With Large Vessel Occlusion: A Pooled Analysis of the EXTEND-IA TNK Trials2022Neurology
Tenecteplase vs. alteplase for acute ischemic stroke: a systematic review2022International Journal of Emergency Medicine
Endovascular treatment with or without intravenous alteplase for acute ischaemic stroke due to basilar artery occlusion2022Stroke and Vascular Neurology
Thrombolytic Salvage of the Frostbitten Upper Extremity: A Systematic Review2022Hand (new York, N.y.)
The safety and effectiveness of early anti-platelet therapy after alteplase for acute ischemic stroke: A meta-analysis2021Journal of Clinical Neuroscience : Official Journal of the Neurosurgical Society
Intravenous Thrombolysis With Tenecteplase in Patients With Large Vessel Occlusions: Systematic Review and Meta-Analysis2021Stroke
Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data2020Lancet (london, England)
Thrombolysis in massive and submassive pulmonary embolism during pregnancy and the puerperium: a systematic review2020Journal of Thrombosis and Thrombolysis
Thrombolysis for acute ischemic stroke in the unwitnessed or extended therapeutic time window2020Neurology
Intravenous thrombolysis with 0.9 mg/kg alteplase for acute ischaemic stroke: a network meta-analysis of treatment delay2020Postgraduate Medical Journal

Clinical Practice Guidelines