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Can Clot-Busters overcome blood thinners to save brains?

NCT ID NCT06571149

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial investigates whether giving clot-busting drugs (tenecteplase or alteplase) to people who have an ischemic stroke while taking direct oral anticoagulants (blood thinners) is safe and effective. About 906 adults who had a stroke within 48 hours of taking a DOAC will be randomly assigned to receive either the clot-buster plus standard care, or standard care alone. The goal is to see if the clot-buster improves recovery at 90 days compared to standard treatment.

What this could mean

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

Active substance
Tenecteplase or Alteplase (clot-busting drugs given intravenously)
What this could lead to
If successful, this could expand stroke treatment options for patients on blood thinners, potentially improving recovery and reducing disability.
What could go wrong
The trial is still testing safety and efficacy; there is a risk of bleeding, and results may not confirm benefit in this specific patient group.

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 906 people

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

Started

Mar 2025

Expected to finish

Apr 2029

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: * Informed consent (deferred consent when possible according to national legislation) * AIS eligible to receive intravenous alteplase/tenecteplase as per standard of care disabling according to the judgement of the treating physician * DOAC ingestion within 48 hours prior to enrollment, or patient with an ongoing prescription of DOAC but exact time point of last intake is unknown. * Either * Can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time OR * MRI showing a pattern of "DWI-FLAIR-mismatch", i.e. acute ischemic lesion visibly on DWI ("positive DWI") but no marked parenchymal hyperintensity visible on FLAIR ("negative FLAIR") indicative of an acute ischemic lesion ≤4.5 hours of age AND Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening). Exclusion Criteria: * Contra-indications to IVT by the current standard of care of the treating physicians with the exception of recent DOAC intake as specified above. * Intended reversal by specific or unspecific reversal agents * Pregnancy or lactating women. To be reasonable sure to exclude women with ongoing pregnancy, women are not considered of childbearing potential if they fulfill the following criteria * Age \> 55 years OR * Age \< 55 years and at least 12 months since last menstrual period OR * Have had a documented surgical sterilization * Patient \< 18 years of age (since the benefit of IVT is unproven in this population) Since the benefit of IVT might be smaller in patients in which additional endovascular treatment is planned, the investigators will cap patients with intended mechanical thrombectomy at 20% of the trial population. If this number is reached, the following additional exclusion criterion will be applied: * Intended treatment with endovascular reperfusion strategies

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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.

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

    102 sites in 12 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

  • "Attikon" University Hospital

    NOT_YET_RECRUITING

    Athens, 12462, Greece

  • 2nd Department of Neurology, School of Medicine Faculty of Health Sciences, Aristotle University of Thessaloniki

    NOT_YET_RECRUITING

    Thessaloniki, 546 36, Greece

  • AP-HP, Lariboisière

    NOT_YET_RECRUITING

    Paris, 75019, France

  • AP-HP, Pitié-Salpêtrière

    NOT_YET_RECRUITING

    Paris, 75013, France

  • AZ Groeninge, Campus Kennedy

    RECRUITING

    Kortrijk, Belgium

  • AZ Sint-Jan Brugge AV

    RECRUITING

    Bruges, Belgium

  • Academic Medical Center Amsterdam, Department of Neurology

    RECRUITING

    Amsterdam, 1105, Netherlands

  • Akershus Hospital

    RECRUITING

    Oslo, Norway

  • Albert Schweitzer ziekenhuis

    NOT_YET_RECRUITING

    Dordrecht, 3318, Netherlands

  • Alfried Krupp Krankenhaus

    NOT_YET_RECRUITING

    Essen, 45131, Germany

  • Amphia Hospital

    RECRUITING

    Breda, 4818, Netherlands

  • Asklepios Klinik Barmbek

    NOT_YET_RECRUITING

    Hamburg, 22307, Germany

  • Asklepios Klinik Wandsbek

    RECRUITING

    Hamburg, Germany

  • Barmherzige Brüder Krankenhaus Eisenstadt

    RECRUITING

    Eisenstadt, 7000, Austria

  • Barmherzige Brüder Krankenhaus Wien

    RECRUITING

    Vienna, 1020, Austria

  • CHU Bordeaux

    NOT_YET_RECRUITING

    Bordeaux, 33000, France

  • CHU Montpellier

    NOT_YET_RECRUITING

    Montpellier, 34 295, France

  • CHU Nancy

    NOT_YET_RECRUITING

    Nancy, 54035, France

  • CHU de Lille

    NOT_YET_RECRUITING

    Lille, 59037, France

  • CHU de Liège

    NOT_YET_RECRUITING

    Liège, 4000, Belgium

  • Catharina Ziekenhuis

    NOT_YET_RECRUITING

    Eindhoven, 5623, Netherlands

  • Christian Doppler Klinik

    RECRUITING

    Salzburg, 5020, Austria

  • Chu Grenoble Alpes

    NOT_YET_RECRUITING

    Grenoble, 38043, France

  • Cliniques Universitaires de Bruxelles

    RECRUITING

    Brussels, Belgium

  • Department of Neurology University Hospital of Alexandroupolis Democritus University of Thrace

    NOT_YET_RECRUITING

    Alexandroupoli, 68100, Greece

  • Department of Neurology, School of Medicine University of Crete

    NOT_YET_RECRUITING

    Heraklion, 71500, Greece

  • Eginition Hospital

    NOT_YET_RECRUITING

    Athens, 11528, Greece

  • Ente Ospedaliero Cantonale Istituto di Neuroscienze Cliniche della Svizzera Italiana Stroke Center EOC, Clinica di Neurologia c/o Ospedale Regionale di Lugano, sede Civico

    NOT_YET_RECRUITING

    Lugano, 6903, Switzerland

  • Erasmus Medical Center

    NOT_YET_RECRUITING

    Rotterdam, 3015, Netherlands

  • Franciscus Gasthuis

    NOT_YET_RECRUITING

    Rotterdam, 3045, Netherlands

  • GHU Paris Psychiatrie et Neurosciences, Sainte Anne

    RECRUITING

    Paris, 75014, France

  • Haaglanden MC, HMC Westeinde

    RECRUITING

    The Hague, 2512, Netherlands

  • Haga Ziekenhuis

    RECRUITING

    The Hague, 6815, Netherlands

  • Hamilton Health Sciences

    NOT_YET_RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Heidelberg University Hospital

    RECRUITING

    Heidelberg, 69120, Germany

  • Helios Klinik Schleswig GmbH, Klinik für Neurologie und Neurologische

    RECRUITING

    Schleswig, Germany

  • Helios Klinikum Erfurt GmbH

    RECRUITING

    Erfurt, 99089, Germany

  • Helsinki University Central Hospital

    RECRUITING

    Helsinki, 00290, Finland

  • Hospitais da Universidade de Coimbra

    NOT_YET_RECRUITING

    Coimbra, 3004-561, Portugal

  • Hospital Amadora-Sintra Fernando Fonseca

    NOT_YET_RECRUITING

    Amadora, 2720-276, Portugal

  • Hospital Dr. Nélio Mendonça

    RECRUITING

    Funchal, 9000-177, Portugal

  • Hospital Egas Moinz

    RECRUITING

    Lisbon, 1449-005, Portugal

  • Hospital Pedro Hispano

    RECRUITING

    Matosinhos Municipality, 4464-513, Portugal

  • Hospital de Santo António

    RECRUITING

    Porto, 4099-001, Portugal

  • Hospital de São João

    RECRUITING

    Porto, 4200-319, Switzerland

  • Hôpital Civil Marie Curie

    RECRUITING

    Charleroi, Belgium

  • Hôpital FOCH

    NOT_YET_RECRUITING

    Suresnes, 92150, France

  • Hôpital Paris Saint-Joseph

    NOT_YET_RECRUITING

    Paris, 75014, France

  • Hôpital Pierre Wertheimer

    NOT_YET_RECRUITING

    Lyon, 69677, France

  • Hôpital de Hautepierre

    NOT_YET_RECRUITING

    Strasbourg, 67098, France

  • Hôpitaux Universitaires Genève

    RECRUITING

    Geneva, 1205, Switzerland

  • Inselspital Bern

    RECRUITING

    Bern, 3010, Switzerland

  • Isala Hospital

    NOT_YET_RECRUITING

    Zwolle, 8025, Netherlands

  • Kantonsspital Baden AG

    RECRUITING

    Baden, 5404, Switzerland

  • Kantonsspital St. Gallen

    RECRUITING

    Sankt Gallen, Switzerland

  • Klinik Hirslanden

    NOT_YET_RECRUITING

    Zurich, 8032, Switzerland

  • Klinikum Kassel

    RECRUITING

    Kassel, 34125, Germany

  • Klinikum der Stadt Ludwigshafen

    RECRUITING

    Ludwigshafen, Germany

  • Klinikum der Universität München

    RECRUITING

    München, 81377, Germany

  • Knappschaft Kliniken Bottrop GmbH

    RECRUITING

    Bottrop, 46242, Germany

  • Lisbon Central University Hospital Centre

    RECRUITING

    Lisbon, 1150-199, Portugal

  • Luzerner Kantonsspital

    RECRUITING

    Lucerne, 6000, Switzerland

  • MEDIN La Tour

    RECRUITING

    Biel, 2502, Switzerland

  • Medical University of Innsbruck

    NOT_YET_RECRUITING

    Innsbruck, 6020, Austria

  • Medizinische Universität Wien

    RECRUITING

    Vienna, 1090, Austria

  • Médecin Associé Service de Neurologie Département des Neurosciences Cliniques CHUV, BH13

    RECRUITING

    Lausanne, 1011, Switzerland

  • Neurologue FMH, AFC EEG/ENMG

    RECRUITING

    Nyon, 1260, Switzerland

  • Nordwest-Krankenhaus Sanderbusch

    RECRUITING

    Sande, 26452, Germany

  • OLVG location East

    NOT_YET_RECRUITING

    Amsterdam, 1091, Netherlands

  • Perpignan Hospital Center

    NOT_YET_RECRUITING

    Perpignan, 66000, France

  • RHÖN-KLINIKUM AG - Campus Bad Neustadt

    RECRUITING

    Bad Neustadt an der Saale, 97616, Germany

  • Radboud University Nijmegen Medical Center

    RECRUITING

    Nijmegen, 6500, Netherlands

  • Rijnstate

    RECRUITING

    Arnhem, 6815, Netherlands

  • RoMed Klinikum Rosenheim Klinik

    NOT_YET_RECRUITING

    Rosenheim, 83022, Germany

  • SRH Klinikum Karlsbad-Langensteinbach GmbH

    RECRUITING

    Karlsbad, Baden-Wurttemberg, 76307, Germany

  • Sana Kliniken Lübeck GmbH

    NOT_YET_RECRUITING

    Lübeck, 23560, Germany

  • Sozialstiftung Bamberg

    NOT_YET_RECRUITING

    Bamberg, 96049, Germany

  • St. Antonius Ziekenhuis

    NOT_YET_RECRUITING

    Nieuwegein, 3435, Netherlands

  • St. Josef-Hospital

    RECRUITING

    Bochum, 44791, Germany

  • Stadtspital Zürich

    RECRUITING

    Zurich, 8063, Switzerland

  • UCL St Luc

    RECRUITING

    Brussels, Belgium

  • ULS de Entre Douro e Vouga

    RECRUITING

    Porto, 4520-211, Portugal

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University General Hospital of Patras

    NOT_YET_RECRUITING

    Pátrai, 265 04, Greece

  • University Hospital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • University Hospital Gent

    RECRUITING

    Ghent, Belgium

  • University Medical Center

    RECRUITING

    Leiden, 2333, Netherlands

  • University Medical Center

    NOT_YET_RECRUITING

    Maastricht, 6229, Netherlands

  • University Medical Center Groningen

    RECRUITING

    Groningen, 9700, Netherlands

  • University Medical Center Utrecht

    RECRUITING

    Utrecht, 3584, Netherlands

  • Universität Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinik für Neurologie Graz

    RECRUITING

    Graz, 8036, Austria

  • Universitätsklinikum Freiburg

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Gießen und Marburg GmbH

    RECRUITING

    Giessen, Germany

  • Universitätsklinikum Jena

    RECRUITING

    Jena, 07747, Germany

  • Universitätsklinikum Tübingen, Abt. Neurologie mit Schwerpunkt neurovaskuläre Erkrankungen

    RECRUITING

    Tübingen, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Universitätsklinikum des Saarlandes

    NOT_YET_RECRUITING

    Homburg, 66421, Germany

  • Universitätsmedizin Frankfurt

    RECRUITING

    Frankfurt, 60590, Germany

  • Universitätsmedizin Göttingen, Abteilung Neurologie

    RECRUITING

    Göttingen, Germany

  • Universitätsspital Zürich

    RECRUITING

    Zurich, 8091, Switzerland

  • Vall d'Hebron Stroke Center

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

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