Alteplase

(Activase®)

Activase®

Drug updated on 9/4/2024

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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  • Activase (alteplase) is indicated for the treatment of Acute Ischemic Stroke (AIS), for the treatment of Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure, and for the treatment of Acute Massive Pulmonary Embolism (PE) for lysis.
  • This summary is based on the review of 17 systematic reviews/meta-analyses. [1-17]
  • No significant difference in 90-day functional outcomes between tenecteplase and alteplase (OR for excellent outcome 1.08, 95% CI 0.93-1.26; OR for poor outcome 0.95, 95% CI 0.75-1.21).
  • Tenecteplase 0.25 mg/kg dose was associated with increased early vessel recanalization (OR 2.07, 95% CI 1.19-3.59) and a higher rate of excellent neurological recovery (OR 1.15, 95% CI 1.01-1.32) compared to alteplase 0.9 mg/kg.
  • Tenecteplase demonstrated significantly better early major neurological improvement in one study (RR 1.56, 95% CI 1.00-2.43) but no significant difference in another (OR 1.26, 95% CI 0.80-1.96).
  • Subgroup analysis suggested that tenecteplase 0.25 mg/kg dose might be more effective than the 0.4 mg/kg dose in certain efficacy outcomes.
  • No significant difference in symptomatic intracerebral hemorrhage (sICH) between tenecteplase and alteplase (OR 1.12, 95% CI 0.79-1.59).
  • Tenecteplase is associated with an increased incidence of any intracranial hemorrhage compared to alteplase (OR 2.24, 95% CI 1.75-2.86), though no significant differences were observed in symptomatic ICH or parenchymal hematoma.
  • Tenecteplase may reduce all-cause mortality compared to alteplase (aOR 0.44, 95% CI 0.30-0.64).
  • Subgroup analyses suggest that tenecteplase at 0.25 mg/kg may offer greater efficacy compared to 0.4 mg/kg, particularly in acute ischemic stroke patients, including those with anterior circulation tandem occlusions where it is favored over alteplase for favorable outcomes, mortality, and early recanalization.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Tenecteplase versus alteplase for the treatment of acute ischemic stroke: a meta-analysis of randomized controlled trials.2024Annals of Medicine
Tenecteplase versus alteplase for acute ischemic stroke: a systematic review and meta-analysis of randomized and non-randomized studies.2024Journal of Neurology
Tenecteplase versus alteplase in acute ischemic stroke: a systematic review and meta-analysis.2024Annals of Neurosciences
Efficacy and safety outcomes of Tenecteplase versus Alteplase for thrombolysis of acute ischemic stroke: a meta-analysis of 9 randomized controlled trials.2024Journal of the Neurological Sciences
Intravenous thrombolysis with tenecteplase versus alteplase combined with endovascular treatment of anterior circulation tandem occlusions: a pooled analysis of ETIS and TETRIS.2024European Stroke Journal
The efficacy and safety of intravenous thrombolysis with tenecteplase versus alteplase for acute ischemic stroke: a systematic review and meta-analysis.2023Neurological Sciences
Tenecteplase vs. alteplase for treatment of acute ischemic stroke: a systematic review and meta-analysis of randomized trials.2023Frontiers in Neurology
Tenecteplase vs. alteplase for intravenous thrombolytic therapy of acute ischemic stroke: a systematic review and meta-analysis.2023Neurology and Therapy
The efficacy and safety of tenecteplase versus alteplase for acute ischemic stroke: an updated systematic review, pairwise, and network meta-analysis of randomized controlled trials.2023Journal of Thrombosis and Thrombolysis
Comparative efficacy and safety of tenecteplase and alteplase in acute ischemic stroke: a pairwise and network meta-analysis of randomized controlled trials.2023Journal of the Neurological Sciences
Different doses of tenecteplase vs. alteplase for acute ischemic stroke within 4.5 hours of symptom onset: a network meta-analysis of randomized controlled trials.2023Frontiers in Neurology
Tenecteplase vs. alteplase for acute ischemic stroke: a systematic review.2022International Journal of Emergency Medicine
Tenecteplase vs. alteplase for acute ischemic stroke: a systematic review.2022International Journal of Emergency Medicine
Tenecteplase vs. alteplase for the treatment of patients with acute ischemic stroke: a systematic review and meta-analysis.2022Journal of Neurology
The safety and effectiveness of early anti-platelet therapy after alteplase for acute ischemic stroke: a meta-analysis.2021Journal of Clinical Neuroscience
Related factors with orolingual angioedema after intravenous alteplase in acute ischemic stroke: results from a single-center cohort and meta-analysis.2021Neurological Sciences
Safety and efficacy of repeated thrombolysis with alteplase in early recurrent ischemic stroke: a systematic review.2019Journal of Stroke & Cerebrovascular Diseases

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