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Stroke breakthrough? drug may clear residual clots after standard treatment

NCT ID NCT05499832

Disease control Sponsor: Insel Gruppe AG, University Hospital Bern 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether giving a clot-dissolving drug called tenecteplase directly into the brain artery can improve blood flow in stroke patients who still have blockages after standard mechanical clot removal. 156 adults with acute ischemic stroke were randomly assigned to receive either the drug or best medical care. The study aims to see if this extra step leads to better reperfusion and less disability at 90 days.

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 given directly into the brain artery)
What this could lead to
If it works, this could offer a way to restore more blood flow in stroke patients who still have blockages after standard clot removal, potentially reducing disability.
What could go wrong
This is a relatively small, early-stage proof-of-concept trial, so results may not be definitive. The drug also carries a risk of 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

156 people

The number who actually took part.

Started

Mar 2023

Finished

Oct 2025

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 * Informed consent * Age ≥18 years * Clinical signs consistent with an acute ischemic stroke * Patient had an initial vessel occlusion in the anterior or posterior circulation defined as intracranial ICA, M1, M2, M3, A1, A2, P1 or P2 * Patient has undergone endovascular stroke treatment * Onset to randomization no later than \< 705 minutes (11h 45min) after symptom-onset/last-seen well. * Incomplete reperfusion defined as any of the following: 1. For ICA/M1: TICI2b/2c (50-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist). 2. For A1/A2, P1/P2, M2/M3: TICI2a/2b/2c (1-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist). 3. Any emboli to new territory without mechanically amendable target-occlusion (as per definition by the interventionalist). * Signs of early ischemic changes of non-contrast CT Alberta Stroke Program Early CT Score (ASPECTS) ≥5 (for DWI-ASPECTS ≥ 4, for DWI-ASECTS: a region must have diffusion abnormality in 20% or more of its volume to be considered DWI-ASPECTS positive) Exclusion Criteria * Acute intracranial hemorrhage * Contraindication to MRI (e.g. pacemaker) * Any severe bleeding within the past 6 months, which would prevent administration of intravenous thrombolysis in clinical routine Major surgery in the past 2 months with severe risk of bleeding, which would prevent administration of intravenous thrombolysis in clinical routine * Intake of Vitamin K antagonists with INR \>1.7 * Platelets \< 50,000 * Non-controlled hypertension (defined as SBP \>185 mmHg or DBP \>110 mmHg refractory to treatment) * Active dyspeptic ulcer * Known arterial aneurysm * Known neoplasms with risk of bleeding * Severe liver fibrosis or portal hypertension * Acute pericarditis * Acute endocarditis * Acute pancreatitis * Known allergy to TNK or Gentamicin or other additives/auxiliaries (Polysorbatum 20, L-Argininum, Acidum phosphoricum) * Known Renal failure either as defined by a serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate \[GFR\] \< 30 or as subject who required hemodialysis/peritoneal dialysis * Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma) * Radiological confirmed evidence of cerebral vasculitis * Calcified thrombi * Pregnancy or lactating women

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Conditions

The condition(s) this trial relates to.

ischemic stroke large artery stroke

As listed by the trial registrant

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

Ischemic stroke

Contacts and locations

Locations

  • AZ Sint Jan Brugge AV

    Bruges, 8000, Belgium

  • Amsterdam UMC

    Amsterdam, 1100, Netherlands

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011, Switzerland

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, 1011, Switzerland

  • Christian-Doppler-Klinik Salzburg

    Salzburg, 5020, Austria

  • Clinique CHC MontLégia

    Liège, 4000, Belgium

  • Cliniques universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Helios Klinikum Erfurt

    Erfurt, 99089, Germany

  • Hospital Eagas Moniz

    Lisbon, 1349-019, Portugal

  • Hospital Nelio Mendonca Funchal

    Funchal, 9000-177, Portugal

  • Hospital Santo Antonio

    Porto, 4099-001, Portugal

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Hôpital universitaires de Bruxelles

    Anderlecht, 1070, Belgium

  • Hôpitaux universitaires de Genève

    Geneva, 1211, Switzerland

  • Johannes Wesling Klinikum Minden

    Minden, 32429, Germany

  • Kantonsspital Aarau

    Aarau, 5001, Switzerland

  • Kantonsspital Aarau

    Aarau, Switzerland

  • Kantonsspital Aarau AG

    Aarau, 5001, Switzerland

  • Kantonsspital Luzern

    Lucerne, 6000, Switzerland

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007, Switzerland

  • Kepler Universitätsklinikum GmbH

    Linz, 4020, Austria

  • Klinikum Bremen-Mitte

    Bremen, 28205, Germany

  • Klinikum der Universität München

    München, 81377, Germany

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675, Germany

  • LKH-Universitätsklinikum Graz

    Graz, 8036, Austria

  • Leiden UMC

    Leiden, 2300, Netherlands

  • Lisbon Central University Hospital

    Lisbon, 1150-199, Portugal

  • Medizinische Universität Innsbruck

    Innsbruck, 6020, Austria

  • Ospedale Regionale di Lugano

    Lugano, 6900, Switzerland

  • Städtisches Klinikum Sollingen

    Solingen, 42653, Germany

  • UZ Brussel

    Brussels, 1050, Belgium

  • UZ Gasthuisberg Leuven

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University Hospital Helsinki

    Helsinki, 00029, Finland

  • University Hospital of Lausanne

    Lausanne, Switzerland

  • Universitätsklinikum Augsburg

    Augsburg, 86156, Germany

  • Universitätsklinikum Bonn

    Bonn, 53127, Germany

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, 01307, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, 60528, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Halle (Saale)

    Halle, 06120, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Magdeburg A. ö. R.

    Magdeburg, 39120, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsmedizin Göttingen

    Göttingen, 37075, Germany

  • Universitätsmedizin Mannheim

    Mannheim, 68167, Germany

  • Universitätsspital Basel

    Basel, Switzerland

  • Universitätsspital Bern

    Bern, 3010, Switzerland

  • Universitätsspital Zürich

    Zurich, 8091, Switzerland

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