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Stroke drug dosing trial aims to improve recovery for thousands

NCT ID NCT06320431

Disease control Sponsor: University of Calgary Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial is testing two different doses of the clot-busting drug tenecteplase in 4,000 people who have had an acute ischemic stroke. The goal is to find out which dose works best and is safest, especially for patients who have taken blood thinners or are undergoing a procedure to remove the clot. Researchers will track patients for 90 days to see how well they recover and whether they have any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tenecteplase (a clot-busting drug)
What this could lead to
If successful, this trial could identify the safest and most effective dose of tenecteplase for different stroke patients, potentially improving recovery and reducing disability.
What could go wrong
This is an early-phase study with 4,000 participants, and results may not apply to all stroke patients. There is a risk of bleeding, a known side effect of clot-busting drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 4,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. All patients with disabling AIS presenting within 4.5 hours of symptom onset or last known well who may benefit from intravenous thrombolysis (IVT) with tenecteplase. Patients potentially eligible for IVT with conditions described as relative contraindications in national guidelines where physician discretion is recommended are eligible. Patients who received a DOAC, and those planned for emergency EVT are eligible. 2. Consent process completed as per national laws and regulation and the applicable ethics committee requirements. Exclusion Criteria: 1. Any absolute contraindication for IV thrombolysis per current national guidelines. Examples include those who are actively bleeding, had recent intracranial surgery, head trauma, intracranial or subarachnoid hemorrhage, or a bleeding diathesis. 2. Minor stroke patients with non-disabling symptoms.

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Conditions

The condition(s) this trial relates to.

ischemic stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke (AIS) Stroke, acute Stroke, acute, stroke ischemic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brandon Regional Hospital

    NOT_YET_RECRUITING

    Brandon, Manitoba, Canada

  • CIUSSS de l'Estrie - CHUS Fleurimont Hôpital (Sherbrooke)

    NOT_YET_RECRUITING

    Sherbrooke, Quebec, Canada

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    NOT_YET_RECRUITING

    Montreal, Quebec, Canada

  • Health Sciences North Horizon Sante-Nord

    RECRUITING

    Greater Sudbury, Ontario, Canada

  • Kelowna Regional Hospital

    NOT_YET_RECRUITING

    Kelowna, British Columbia, Canada

  • Kingston General Hospital

    NOT_YET_RECRUITING

    Kingston, Ontario, Canada

  • Lawson Health Research Institute- London

    NOT_YET_RECRUITING

    London, Ontario, Canada

  • McMaster University Hamilton Health Sciences Centre

    RECRUITING

    Hamilton, Ontario, Canada

  • Medicine Hat Regional Hospital

    NOT_YET_RECRUITING

    Medicine Hat, Alberta, Canada

  • Monash University (Box Hill)

    RECRUITING

    Melbourne, Victoria, Australia

  • Queen Elizabeth Hospital (PEI)

    RECRUITING

    Charlottetown, Prince Edward Island, Canada

  • Queen Elizabeth II Health Science Center (Halifax)

    NOT_YET_RECRUITING

    Halifax, Nova Scotia, Canada

  • Red Deer Regional Hospital

    NOT_YET_RECRUITING

    Red Deer, Alberta, Canada

  • Royal Columbian Hospital

    NOT_YET_RECRUITING

    New Westminster, British Columbia, Canada

  • Royal Prince Alfred Hospital

    RECRUITING

    Sydney, New South Wales, Australia

  • Royal University Hospital

    RECRUITING

    Saskatoon, Saskatchewan, Canada

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • Sunnybrook Health Science Centre

    RECRUITING

    Toronto, Ontario, Canada

  • The George Institute for Global Health

    NOT_YET_RECRUITING

    Sydney, Barangaroo, NSW 2000, Australia

  • University of Alberta

    RECRUITING

    Edmonton, A, Canada

  • University of British Columbia

    RECRUITING

    Vancouver, British Columbia, Canada

  • University of Calgary

    RECRUITING

    Calgary, Alberta, T2N 1N4, Canada

  • University of Manitoba - Winnipeg Health Science Centre

    RECRUITING

    Winnipeg, Manitoba, Canada

  • University of Ottawa

    RECRUITING

    Ottawa, Ontario, Canada

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