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Can half the Clot-Busting drug save lives with less bleeding?

NCT ID NCT07816978

Disease control Sponsor: Sahlgrenska University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

Researchers are testing whether a lower dose of the clot-dissolving drug alteplase can treat life-threatening pulmonary embolism as effectively as the standard full dose while causing less severe bleeding. The trial enrolls adults with acute high-risk pulmonary embolism, a condition where a clot blocks blood flow to the lungs. Participants receive either reduced-dose or full-dose alteplase and are followed for up to a year to compare survival, clot recurrence, and major bleeding.

What this could mean

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

Active substance
alteplase, a clot-dissolving drug given intravenously
What this could lead to
If reduced-dose alteplase works as well as the full dose, doctors could treat life-threatening pulmonary embolism with less bleeding risk.
What could go wrong
The lower dose might not break up clots fast enough in critically ill patients, and bleeding remains a risk with any thrombolysis. Results may not apply to all patients with pulmonary embolism.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 400 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jan 2031

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 aged 18 years or older. 2. Acute pulmonary embolism verified by computed tomography pulmonary angiography or pulmonary angiography. In hemodynamically unstable participants unable to undergo immediate imaging, presumed pulmonary embolism may be diagnosed based on bedside echocardiographic findings consistent with acute right ventricular pressure overload and high clinical suspicion of pulmonary embolism, provided that alternative causes of hemodynamic instability have been reasonably excluded. In such cases, the treating clinician must have independently decided to initiate thrombolytic therapy irrespective of study participation, and confirmatory imaging demonstrating pulmonary embolism must be performed as soon as clinically feasible. 3. High risk for early death, defined by at least one of the following: 1. High-risk pulmonary embolism according to European Society of Cardiology criteria: * Cardiac arrest with return of spontaneous circulation; * Obstructive shock, defined as systolic blood pressure \<90 mmHg or use of vasopressors to maintain systolic blood pressure ≥90 mmHg despite adequate filling status, together with end-organ hypoperfusion such as elevated serum lactate \>2 mmol/L, altered mental status, or cold clammy skin; * Persistent hypotension, defined as systolic blood pressure \<90 mmHg or a drop in systolic blood pressure ≥40 mmHg for longer than 15 minutes, not caused by new-onset arrhythmia, hypovolemia, or sepsis. 2. Abnormal right ventricular function on echocardiography or computed tomography pulmonary angiography, defined as right ventricular/left ventricular ratio ≥1.0, and elevated cardiac troponin above the local upper reference limit, and acute respiratory failure not primarily caused by underlying lung disease, defined as requiring facemask oxygen supplementation ≥12 L/min, high-flow nasal oxygen, or non-invasive ventilation with FiO2 ≥60% to reach oxygen saturation ≥94%. 4. Female participants of childbearing potential must have a negative urine or serum pregnancy test. Exclusion Criteria: 1. Catastrophic pulmonary embolism, defined as ongoing cardiac arrest and/or need for extracorporeal cardiopulmonary resuscitation and/or immediate VA-ECMO as judged by the treating physicians. 2. Known hypersensitivity to alteplase or any of its excipients. 3. Contraindication to systemic thrombolysis with one or more of the following: * History of hemorrhagic stroke; * Ischemic stroke within the previous 6 months; * Central nervous system neoplasm; * Major trauma, major surgery, or major head injury within the previous 3 weeks; * Active life-threatening bleeding, bleeding into a critical organ or area, or known severe bleeding diathesis; * Chronic use of full-dose oral or parenteral anticoagulation before presentation. 4. The participant has already received reperfusion treatment for the index pulmonary embolism before randomization, including systemic thrombolysis, surgical embolectomy, or catheter-directed intervention. 5. Pregnancy. 6. Current participation in another study that would interfere with participation in this trial. 7. Any other condition that would put the participant at unacceptable risk from the trial interventions as judged by the treating clinician. 8. In countries where required by national regulations: lack of affiliation to a social security system or equivalent health insurance coverage.

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Conditions

The condition(s) this trial relates to.

pulmonary embolism

As listed by the trial registrant

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

Pulmonary embolism acute

How to take part

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

  1. The places running it

    23 sites in 3 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

  • Akershus University Hospital

    Lörenskog, 1478, Norway

  • Capio S:t Göran's Hospital

    Stockholm, Sweden

  • Danderyd Hospital

    Stockholm, Sweden

  • Drammen Hospital

    Drammen, 3004, Norway

  • Falun Hospital

    Falun, Sweden

  • Haukeland University Hospital

    Bergen, 5021, Norway

  • Karolinska University Hospital, Huddinge

    Stockholm, Sweden

  • Karolinska University Hospital, Solna

    Stockholm, Sweden

  • Norrtälje Hospital

    Norrtälje, Sweden

  • Oslo University Hospital, Ullevål

    Oslo, 0450, Norway

  • Ostfold Hisptal

    Grålum, 1714, Norway

  • Rigshospitalet

    Copenhagen, Denmark

  • Ryhov County Hospital

    Jönköping, Sweden

  • Sahlgrenska University Hospital

    Gothenburg, Västra Götaland County, 413 45, Sweden

  • Sahlgrenska University Hospital/Mölndal

    Mölndal, Sweden

  • Sahlgrenska University Hospital/Östra

    Gothenburg, Sweden

  • Skaraborgs Hospital Skövde

    Skövde, Sweden

  • Skåne University Hospital, Lund

    Lund, Sweden

  • Skåne University Hospital, Malmö

    Malmö, Sweden

  • Stavanger University Hospital

    Stavanger, 4021, Norway

  • Södersjukhuset, Stockholm South General Hospital

    Stockholm, Sweden

  • University Hospital of Umeå

    Umeå, Sweden

  • Uppsala University Hospital

    Uppsala, Sweden

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