Tenecteplase or Alteplase for Stroke
(ACT-REACT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two treatments for individuals who have experienced an acute ischemic stroke (AIS). The primary goal is to determine if tenecteplase or alteplase, both clot-busting drugs, administered after a procedure called EVT, improves recovery more effectively than standard care alone. Participants will receive one of these treatments or just standard care and will be monitored for 90 days to assess their recovery. Individuals recently diagnosed with a stroke may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both tenecteplase and alteplase have been studied for their safety in treating strokes caused by blocked blood flow to the brain. Tenecteplase has shown promising results, with studies reporting a lower chance of serious brain bleeding compared to other treatments. It is generally safe and well-tolerated, with less bleeding outside the brain compared to alteplase.
Alteplase is effective but can cause significant bleeding inside or outside the body, especially at needle sites. Some studies suggest a higher chance of brain bleeding compared to a placebo (a harmless pill used for comparison). However, these studies did not show an increased risk of death.
Both drugs treat strokes, and research indicates they are generally safe, though each has specific risks. The trial will likely monitor these safety aspects closely.12345Why are researchers excited about this trial's treatments?
Researchers are excited about tenecteplase and alteplase for stroke treatment because they offer a unique approach through local intra-arterial (IA) thrombolysis. Unlike standard intravenous thrombolysis, IA delivery targets the clot directly, which might increase effectiveness and reduce potential side effects. Tenecteplase, in particular, stands out due to its longer half-life and more targeted action compared to alteplase, potentially allowing for a more efficient clot breakdown and a quicker recovery.
What evidence suggests that this trial's treatments could be effective for Acute Ischemic Stroke?
This trial will compare the effectiveness of tenecteplase and alteplase in treating strokes. Research has shown that tenecteplase may effectively treat sudden strokes caused by blocked blood flow to the brain. Approximately 40.5% of patients who received tenecteplase experienced excellent recovery, with little to no disability. Studies have also found that tenecteplase is as safe as alteplase and might even lead to better recovery without increasing the risk of brain bleeding.
Alteplase is a well-known treatment for strokes and has successfully helped patients recover. One study showed that 31% of patients treated with alteplase had a good recovery 3 to 6 months after their stroke. This trial will assess both treatments to determine their effectiveness in reducing disability after a stroke, offering patients a better chance of recovery.678910Who Is on the Research Team?
Bijoy K Menon, MD
Principal Investigator
University of Calgary
Craig Anderson, MD
Principal Investigator
The George Institute
Are You a Good Fit for This Trial?
This trial is for adults who have had an acute ischemic stroke and are undergoing a procedure called endovascular thrombectomy (EVT). Participants must be eligible to receive additional clot-busting medication during the procedure. Specific inclusion or exclusion criteria were not detailed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of local intraarterial thrombolysis using either tenecteplase or alteplase at the end of EVT procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments conducted up to Day 90
What Are the Treatments Tested in This Trial?
Interventions
- Alteplase
- Tenecteplase
Trial Overview
The study compares giving a single dose of either tenecteplase or alteplase (clot-busting drugs) directly into the artery at the end of EVT, plus standard care, versus standard care alone. Which drug is used depends on what's available at each hospital. Patients are randomly assigned to groups.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
The intervention group will receive local intra-arterial (IA) thrombolysis using either tenecteplase at a dose of 0.0625mg/kg "maximum dose of 6.25mg" or alteplase "0.225 mg/kg; maximum dose, 20mg.
No intra-arterial thrombolysis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
The George Institute for Global Health, Australia
Collaborator
Citations
1.
cris.maastrichtuniversity.nl
cris.maastrichtuniversity.nl/en/publications/the-effectiveness-of-thrombolysis-with-intravenous-alteplase-for-The effectiveness of thrombolysis with intravenous ...
Results Overall, 1657 patients with ischemic stroke were admitted within four-hours from onset of symptoms and 696 (42%) were treated with alteplase.
Trends and outcomes of tenecteplase and alteplase usage ...
This study aims to compare the usage trends and outcomes of TNK versus alteplase in acute ischemic stroke. Methods: We conducted retrospective ...
3.
pure.johnshopkins.edu
pure.johnshopkins.edu/en/publications/the-effectiveness-of-thrombolysis-with-intravenous-alteplase-for--3/The effectiveness of thrombolysis with intravenous ...
Results: Overall, 1657 patients with ischemic stroke were admitted within four-hours from onset of symptoms and 696 (42%) were treated with alteplase.
Effectiveness and safety of intravenous alteplase in ...
Overall, intravenous rtPA (alteplase) was found to be effective in reducing NIHSS score from baseline to 7 days. The difference in the score was statistically ...
5.
2minutemedicine.com
2minutemedicine.com/early-alteplase-treatment-leads-to-better-stroke-outcomes-regardless-of-age-or-stroke-severity/Early alteplase treatment leads to better stroke outcomes ...
Overall, 2,110 (31%) of 6,756 patients achieved a good stroke outcome at 3-6 months. Alteplase resulted in greater odds of a good outcome, with ...
Activase® (alteplase) | Treatment for Acute Ischemic Stroke (AIS)
Activase can cause significant, sometimes fatal internal or external bleeding, especially at arterial and venous puncture sites. Avoid intramuscular injections ...
Efficacy and safety of intravenous alteplase for unknown onset ...
In the no prior APT patients, 136 patients (50%) in the alteplase group and 112 patients (45%) in the control group had a favorable outcome (aOR, 1.39 [0.94- ...
Thrombolysis with Alteplase 3 to 4.5 Hours after Acute ...
The overall rate of symptomatic intracranial hemorrhage was increased with alteplase as compared with placebo, but mortality was not affected.
Analyze Process and Outcomes | Activase® (alteplase)
Activase can cause significant, sometimes fatal internal or external bleeding, especially at arterial and venous puncture sites. Avoid intramuscular injections ...
Scientific Rationale for the Inclusion and Exclusion Criteria ...
A meta-analysis of observational studies (n=3178) showed that stroke patients ≥80 years of age receiving alteplase had a 3-fold higher chance of death (OR, ...
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