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Thrombolytic Agent

Tenecteplase (tNK-TPA) for Stroke (AcT 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
Inclusion Criteria: Inclusion criteria is pragmatic and informed by Canadian Best Practices.
All patients with acute ischemic stroke eligible to receive intravenous alteplase as per standard care will be eligible for enrolment in the proposed trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90-120 days after randomization
Awards & highlights

AcT Trial Summary

This trial will compare two treatments for acute ischemic stroke - intravenous tenecteplase and intravenous alteplase. 1600 patients will be enrolled, and the primary outcome measure is the rate of disability-free survival at 90-120 days.

Eligible Conditions
  • Stroke
  • Intracranial Thrombosis

AcT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

AcT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during evt administration-baseline- after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and during evt administration-baseline- after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Modified Rankin Scale (mRS) 0-1 (freedom from disability)
Secondary outcome measures
% patients returning to baseline level of functioning
CT-to-puncture time in patients undergoing EVT
Discharge Destination
+6 more
Other outcome measures
Death within 90 days
Number of Patients Diagnosed with a Symptomatic ICH post-acute stroke treatment by CT/MRI

AcT Trial Design

2Treatment groups
Active Control
Group I: Tenecteplase (tNK-TPA)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. Tenecteplase has a longer half-life, is more fibrin specific, produces less systemic depletion of circulating fibrinogen, and is more resistant to plasminogen activator inhibitor than alteplase.
Group II: Alteplase ( tPA)Active Control1 Intervention
The control group will receive standard of care dosing of intravenous alteplase (0.9 mg/kg body weight, 10% bolus and 90% infusion as per standard care, maximum dose 90 mg).

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
780 Previous Clinical Trials
840,134 Total Patients Enrolled
29 Trials studying Stroke
12,686 Patients Enrolled for Stroke
Bijoy K Menon, MDPrincipal InvestigatorUniversity of Calgary
Michael D Hill, MDStudy DirectorUniversity of Calgary
6 Previous Clinical Trials
1,808 Total Patients Enrolled
4 Trials studying Stroke
1,660 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.

Yes, can you tell us about other research that has used Tenecteplase (tNK-TPA)?

"There are 33 on-going clinical trials evaluating Tenecteplase (tNK-TPA), with the majority of these studies being Phase 3 trials. 23 of these trials are based in Beijing, but there are a total of 743 research sites for Tenecteplase (tNK-TPA) across the world."

Answered by AI

Are there any open slots in this experiment for new test subjects?

"This particular study is not presently enrolling patients but there are 33 other trials for Tenecteplase (tNK-TPA) that are. If you're seeking other studies, 1280 trials involving wake-up stroke are actively recruiting participants."

Answered by AI
Recent research and studies
~305 spots leftby Mar 2025