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Could a clot-busting drug help stroke patients on blood thinners? new trial aims to find out.

NCT ID NCT07621796

Disease control Sponsor: Hackensack Meridian Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the clot-busting drug tenecteplase is safe and effective for people having a stroke who took a blood thinner (DOAC) within the last 48 hours. About 660 adults will receive either tenecteplase or a placebo within 4.5 hours of stroke symptoms. The goal is to see if the drug reduces disability at 90 days without causing dangerous bleeding in the brain.

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 660 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2032

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: * Adults (18 years or older) with a suspected acute ischemic stroke and clearly disabling deficits * Presenting within 4.5 hours of last known well * Able to initiate intravenous thrombolysis within 4.5 hours of last known well * On recent DOAC therapy (dabigatran, apixaban, rivaroxaban, edoxaban) and known last dose taken within 48 hours from thrombolysis. Exclusion Criteria: * Current or history of intracerebral hemorrhage * Non-disabling deficits * Bleeding disorder (e.g. hemophilia) or advanced liver disease or known INR \> 1.7 within 6 hours * Use of therapeutic low molecular weight heparin or therapeutic dose heparin with elevated PTT * ASPECTS \< 6 or clear hypodensity on CT suggestive of completed infarct * Advanced kidney disease (eGFR \< 30 ml/min) * Known or suspected aortic dissection * Known or high suspicion for infective endocarditis * Surgery within 2 weeks * Intracranial or intraspinal surgery within 3 months * Active internal bleeding or gastrointestinal or urinary tract hemorrhage within 3 weeks * Intracranial neoplasm, arterio-venous malformation, or cavernous malformation * Major head trauma or ischemic stroke within 3 months * Known thrombocytopenia (platelets \< 100,000) * Planned endovascular treatment within 30 minutes of study drug administration (i.e., consent, randomization and administration of study drug must occur at least 30 minutes prior to groin puncture; standard care is not to be delayed and patients in whom endovascular therapy will start sooner will not be enrolled) * Comorbid condition with life expectancy of less than 3 months * Any condition that precludes thrombolytic therapy as determined by site principal investigator * Pregnancy

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

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

Acute ischemic stroke

How to take part

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

  1. The places running it

    1 site. 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

  • Hackensack Meridian Health - Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

More trials for these conditions

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