Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke.
Bruce C V Campbell, Peter J Mitchell, Leonid Churilov...
https://pubmed.ncbi.nlm.nih.gov/29694815Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06498323
Intravenous Tenecteplase Versus Alteplase for Acute Ischemic Stroke Treatment on Mobile Stroke Units, a Prospective Multicenter Randomized Controlled Trial
Led by Mahidol University · Updated on 2024-07-12
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two drugs, intravenous tenecteplase and intravenous alteplase, for treating acute ischemic stroke. This condition can cause serious disability and death, and timely treatment is crucial. Tenecteplase is a newer drug with potential advantages, such as easier administration and longer action, compared to the standard alteplase. The study aims to compare these treatments when given on mobile stroke units within 4.5 hours of stroke symptom onset. Participants will be randomly assigned to receive either tenecteplase at a dose of 0.25 mg/kg or alteplase at 0.9 mg/kg intravenously. Both treatments are administered on mobile stroke units shortly after stroke symptoms begin. This study is a prospective multicenter randomized controlled trial conducted by Mahidol University to assess which drug may offer better neurological outcomes and safety in the early treatment of stroke. During the trial, researchers will monitor participants' neurological status using the modified Rankin Scale (mRS) score at 3 months and the National Institutes of Health Stroke Scale (NIHSS) score at 24 hours. The study includes follow-up visits to assess recovery and any side effects. Participation involves receiving study treatment promptly and attending scheduled assessments to track progress and safety over time.
CONDITIONS
Brief Title
Intravenous TNK vs TPA for AIS Treatment on MSU,a Prospective Multicenter RCT
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute ischemic stroke within 4.5 hours of symptom onset
- Age over 18 years
- No contraindications for thrombolytic drugs
- Able to provide informed consent
You will not qualify if you...
- Stroke symptom onset more than 4.5 hours ago or time of onset unknown
- Contraindications to thrombolytic drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 4.5 hours from symptom onset
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person on mobile stroke units)
Treatment
Duration - Single treatment within 4.5 hours of symptom onset
Participants receive intravenous thrombolytic treatment with either tenecteplase or alteplase on mobile stroke units.
1 treatment visit (in-person on mobile stroke units)
Follow-up
Duration - 3 months
Participants are monitored for recovery and outcomes after treatment.
Follow-up visits with assessments at 24 hours and 3 months
Trial Site Locations
Total: 1 location
1
Siriraj Stroke Center,Siriraj Hospital
Bangkok, Thailand, 10700
Actively Recruiting
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Research Team
Y
Yongchai Nilanont
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Alteplase versus tenecteplase for thrombolysis after ischaemic stroke (ATTEST): a phase 2, randomised, open-label, blinded endpoint study.
Xuya Huang, Bharath Kumar Cheripelli, Suzanne M Lloyd...
https://pubmed.ncbi.nlm.nih.gov/25726502Phase IIB/III trial of tenecteplase in acute ischemic stroke: results of a prematurely terminated randomized clinical trial.
E Clarke Haley, John L P Thompson, James C Grotta...
https://pubmed.ncbi.nlm.nih.gov/20185783A randomized trial of tenecteplase versus alteplase for acute ischemic stroke.
Mark Parsons, Neil Spratt, Andrew Bivard...
https://pubmed.ncbi.nlm.nih.gov/22435369Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial.
Nicola Logallo, Vojtech Novotny, Jörg Assmus...
https://pubmed.ncbi.nlm.nih.gov/28780236Tenecteplase versus Alteplase for the Management of Acute Ischemic Stroke in a Low-income Country-Nepal: Cost, Efficacy, and Safety.
Gaurav Nepal, Ghanshyam Kharel, Shaik Tanveer Ahamad...
https://pubmed.ncbi.nlm.nih.gov/29651371Should Tenecteplase Replace Alteplase for Acute Thrombolysis?
Keith W Muir
https://pubmed.ncbi.nlm.nih.gov/33588587Tenecteplase Versus Alteplase Between 3 and 4.5 Hours in Low National Institutes of Health Stroke Scale.
Ole Morten Rønning, Nicola Logallo, Bente Thommessen...
https://pubmed.ncbi.nlm.nih.gov/30602354Intravenous Thrombolysis With Tenecteplase in Patients With Large Vessel Occlusions: Systematic Review and Meta-Analysis.
Aristeidis H Katsanos, Apostolos Safouris, Amrou Sarraj...
https://pubmed.ncbi.nlm.nih.gov/33272127Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke.
Werner Hacke, Markku Kaste, Erich Bluhmki...
https://pubmed.ncbi.nlm.nih.gov/18815396