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Could stroke patients on blood thinners finally get clot-busting treatment?

NCT ID NCT06878066

Disease control Sponsor: Guri Hagberg 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 2 times

Summary

This study tests whether clot-busting drugs (alteplase or tenecteplase) are safe and effective for stroke patients who have taken a blood thinner (FXa inhibitor) in the last 48 hours. Current guidelines avoid this treatment due to bleeding concerns, but new evidence suggests it may be safe. The trial will compare 300 patients who receive the clot-buster with those who get standard care, measuring recovery and bleeding risks.

What this could mean

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

Active substance
Alteplase or Tenecteplase (clot-busting drugs)
What this could lead to
If successful, this could change stroke treatment guidelines so that more patients on blood thinners can receive life-saving clot-busting therapy without delay.
What could go wrong
This is a phase 3 trial, but results may not apply to all patients. There is a risk of brain bleeding, and the study does not require a blood test to measure drug levels before treatment.

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 300 people

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

Started

Mar 2025

Expected to finish

Dec 2037

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. Participant must be 18 years of age or older. 2. Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown) 3. Clinical diagnosis of AIS with disabling neurological deficit 4. Presenting within 4.5 h of symptom onset or after awakening with symptoms of AIS with FLAIR-DWI mismatch on MRI as judged by the (neuro-) radiologist. 5. Informed consent Exclusion Criteria: 1. Endovascular treatment eligible patients with isolated large vessel occlusion of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography and expected time from randomization to groin puncture of \<30 minutes. 2. Systolic BP \>185 mmHg or diastolic BP \>110 mmHg despite antihypertensive treatment. 3. Known bleeding diathesis; manifest or recent severe bleeding; significant bleeding disorder last 6 months. 4. Arterial puncture at a non-compressible site; biopsy or lumbar puncture \<7 days; major surgery, traumatic external heart massage, obstetrical delivery or serious trauma \<14 days; history of intracranial haemorrhage; stroke \<2 months, CNS neurosurgery \<2 months; serious head trauma \<2 months; pericarditis; sepsis; bacterial endocarditis; pericarditis; acute pancreatitis; neoplasm with increased bleeding risk; any serious medical illness likely to interact with treatment (i.e. aortic dissection); confounding pre-existent neurological or psychiatric disease. 5. Any condition that, in the opinion of the treating physician, puts a patient at risk if treated with thrombolysis (i.e. signs of cerebral hemorrhage, known cerebral amyloid angiopathy, CT with signs of early ischemia greater than one-third of the middle cerebral artery territory). Prior/Concomitant Therapy 6. Use of a) direct thrombin (II) inhibitor (Dabigatran) or b) warfarin with an INR ≥1.8; c) heparin \<48 h; d) treatment dose of LMWH \<24 h. Prior/Concurrent Clinical Study Experience 7. Hypersensitivity to Alteplase or Tenecteplase

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Conditions

The condition(s) this trial relates to.

hemorrhagic stroke intracerebral hemorrhage Intracranial Hemorrhages ischemic stroke stroke disorder

As listed by the trial registrant

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

Acute ischemic stroke Anticoagulant therapy Bleeding in the brain Factor xa inhibitor Hemorrhagic transformation due to acute stroke Intracranial hemorrhages Ischemic stroke Stroke Stroke (in patients with atrial fibrillation)

How to take part

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

  1. The places running it

    14 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

  • Dept of Medicine, Haraldsplass deaconal Hospital

    RECRUITING

    Bergen, 5009, Norway

  • Dept of Medicine, Helse More and Romsdal Health Trust, Aalesund Hospital

    RECRUITING

    Ålesund, 6017, Norway

  • Dept of Neurology, Drammen Hospital Trust

    RECRUITING

    Drammen, 3004, Norway

  • Dept of Neurology, Hospital of Southern Norway, SSHF

    RECRUITING

    Kristiansand, 4615, Norway

  • Dept of Neurology, Innlandet Hospital Trust, Lillehammer

    RECRUITING

    Lillehammer, 2609, Norway

  • Dept of Neurology, Ostfold Hospital Trust, Kalnes

    RECRUITING

    Grålum, 1714, Norway

  • Dept of Neurology, Stavanger University Hospital

    RECRUITING

    Stavanger, 4011, Norway

  • Dept of Neurology, Vesfold Hospital Trust, Tonsberg

    RECRUITING

    Tønsberg, 3103, Norway

  • Dept. Of Medicine, St.Olav Hospital, Trondheim

    RECRUITING

    Trondheim, 7030, Norway

  • Dept. Of Neurology, Haukeland University Hopsital

    RECRUITING

    Bergen, 5009, Norway

  • Dept. of Medicine, Baerum Hospital

    RECRUITING

    Baerum, Gjettum, 1346, Norway

  • Dept. of Neurology, Aalborg Universitetshospital

    RECRUITING

    Aalborg, Aalborg, 9000, Denmark

  • Dept. of Neurology, Oslo University Hospital

    RECRUITING

    Oslo, 0450, Norway

  • Dept. of Neurology, Tromso University Hospital

    RECRUITING

    Tromsø, 9019, Norway

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