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Anti-thrombotic agent
2) IVT with tenecteplase at low-dose: 0.18 mg/kg for Stroke (ACT-WHEN Trial)
Phase 3
Waitlist Available
Led By Bijoy K Menon, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed and evaluated by the central imaging core lab by blinded radiologists/stroke neurologists. these imaging readings will be performed over the course of the trial through study completion.
Awards & highlights
ACT-WHEN Trial Summary
This trial is looking at the effectiveness of different doses of a medication called tenecteplase in treating patients with acute ischemic stroke. They will compare the standard dose of tenecteplase
Who is the study for?
This trial is for up to 4,000 patients with acute ischemic stroke who are considered for intravenous thrombolysis. It's not clear what the specific inclusion or exclusion criteria are, but typically participants would need a confirmed diagnosis and be within a certain time frame from symptom onset.Check my eligibility
What is being tested?
The study compares different doses of tenecteplase (a clot-busting drug) in stroke treatment: standard-dose vs. low-dose, and its use with or without emergency endovascular thrombectomy (EVT). The goal is to find out which approach is more effective for patients including those recently on oral anticoagulants.See study design
What are the potential side effects?
While side effects aren't listed here, common ones associated with tenecteplase include bleeding complications, allergic reactions, and possibly reperfusion injury among others. Each patient's experience may vary.
ACT-WHEN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completed the day the patient is discharged from hospital.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completed the day the patient is discharged from hospital.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
A reduction of functional dependence analyzed across the whole distribution of outcomes assessed on the modified Rankin Scale (mRS)
Secondary outcome measures
90-day mortality
Ambulatory status at discharge
Health-related quality of life, as measured by the EQ-5D-5L at Day 90.
+11 moreACT-WHEN Trial Design
3Treatment groups
Active Control
Group I: Standard-dose intravenous tenecteplase (0.25 mg/kg body weight)Active Control1 Intervention
The intervention group will receive intravenous tenecteplase as a single bolus as per the standard manufacturers' instructions for use. The dose administered will be 0.25 mg/kg body weight (maximum dose 25 mg) over 10-20 seconds as soon as possible after randomization.
Group II: 2) IVT with tenecteplase at low-dose: 0.18 mg/kgActive Control1 Intervention
The intervention group will receive intravenous tenecteplase as a single bolus as per the standard manufacturers' instructions for use. The dose administered will be 0.18 mg/kg body weight (maximum dose 18 mg) over 10-20 seconds as soon as possible after randomization.
Group III: 3) No IV thrombolysis [(only in those undergoing EVT or those on DOACs)Active Control1 Intervention
No intravenous tenecteplase only applied to subjects on DOACs over the last 24 hours or those planned for emergency EVT
Find a Location
Who is running the clinical trial?
The George Institute for Global Health, AustraliaOTHER
18 Previous Clinical Trials
45,180 Total Patients Enrolled
3 Trials studying Stroke
7,604 Patients Enrolled for Stroke
University of CalgaryLead Sponsor
792 Previous Clinical Trials
865,154 Total Patients Enrolled
33 Trials studying Stroke
36,335 Patients Enrolled for Stroke
Bijoy K Menon, MDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
1,600 Total Patients Enrolled
1 Trials studying Stroke
1,600 Patients Enrolled for Stroke
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available positions for patients to participate in this clinical trial?
"Data from clinicaltrials.gov shows that the current trial, initially listed on April 15th, 2024 and last modified on March 12th, 2024, is not actively seeking participants. However, it's worth noting that there are currently 1430 other studies actively recruiting patients at this time."
Answered by AI
What is the level of safety associated with withholding intravenous thrombolysis for individuals receiving endovascular therapy or those taking direct oral anticoagulants?
"Based on the phase 3 study status and existing safety data, our team rates the safety of not using IV thrombolysis (limited to those receiving EVT or taking DOACs) at level 3."
Answered by AI
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