Tenecteplase for Stroke (ACT-WHEN Trial)

Phase 3

Recruiting

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

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and completed the day the patient is discharged from hospital. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

A reduction of functional dependence analyzed across the whole distribution of outcomes assessed on the modified Rankin Scale (mRS)

Secondary study objectives

90-day mortality

Ambulatory status at discharge

Health-related quality of life, as measured by the EQ-5D-5L at Day 90.

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Do I qualify?Apply below to find out