Taking people in GermanyPhase 3
Tenecteplase for stroke in people already taking blood-thinning tablets
Tests tenecteplase against placebo in adults with ischemic stroke taking anticoagulants.
Key facts
- Who runs it
- University Medical Center Hamburg-Eppendorf
- Where
- Aachen, Altenburg, Asbach, Aschaffenburg, Augsburg, Berlin, Bochum, Bonn, Bremen, Chemnitz, Dortmund, Dresden, Duesseldorf, Erlangen, Frankfurt Am Main, Halle (saale), Hamburg, Hanover, Hoexter, Kiel, Leipzig, Luebeck, Lueneburg, Magdeburg, Mainz, Mannheim, Marburg, Mettmann, Minden, Moenchengladbach, Muenster, Munich, Nuremberg, Oldenburg, Osnabrueck, Potsdam, Regensburg, Stuttgart, Wiesbaden, and Wuerzburg, GermanySee the 42 sites
- Trial code
- Registry title
- Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 668 people, planned
- Started
- 9 Mar 2026
- Expected to end
- 30 Apr 2030
- Type of study
- Interventional
- Record updated
- 28 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who have a disabling acute stroke caused by a blocked blood vessel and who recently took a blood thinner by mouth (a direct oral anticoagulant).
- Age
- 18 years or older
- Sex
- Men and women can both join.
- Disease stage
- Acute ischemic stroke with a disabling deficit and an NIHSS score of at least 2. Symptoms must not be known to have lasted more than 6 hours. Brain imaging must show no bleeding. Some people need extra imaging (perfusion or DWI/FLAIR mismatch) if symptoms may have begun more than 4.5 hours earlier or the start time is unknown.
- Earlier treatment
- Must have taken a direct oral anticoagulant (apixaban, rivaroxaban, edoxaban or dabigatran) within 48 hours before joining.
Main reasons for not taking part
- Any reason that rules out thrombolysis, other than taking a direct oral anticoagulant
- Reversal, or planned reversal, of the blood thinner with idarucizumab or andexanet alfa
- Taking other antithrombotic medicines besides direct oral anticoagulants
- Stenting of a neck or brain artery, coronary angioplasty or any surgery expected within 12 hours
- Serious disability before the stroke (mRS above 3)
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Age ≥ 18 years
- Clinical diagnosis of acute stroke with disabling deficit
- National Institutes of Health Stroke Scale (NIHSS) score at least 2
- Recent intake (within 48 hours prior to enrolment) of a direct oral anticoagulant (apixaban, rivaroxaban, edoxaban, or dabigatran)
- No evidence of any intracranial haemorrhage on cerebral imaging (CT or MRI) performed after stroke onset and no earlier than 60 minutes before enrolment
- Stroke symptoms not known to have been present for > 6 h
- For patients not known to have been awake and without acute stroke symptoms within 4.5 hours prior to enrolment, additional imaging criteria must be satisfied: a) If stroke symptoms are known to have been present for > 4.5 h (late time window): core/penumbra mismatch on MR or CT perfusion imaging; b) If stroke symptoms are not known to have been present for > 4.5 h (unknown time window): core/penumbra mismatch on MR or CT perfusion imaging; or DWI/FLAIR mismatch on MR imaging
Who cannot take part
- Contraindication to intravenous thrombolysis, except DOAC therapy
- Concomitant therapy with antithrombotic medications, except DOACs
- Any anticipated surgical intervention within 12 hours
- Significant pre-stroke disability (mRS > 3)
- Reversal or planned reversal of anticoagulation with idarucizumab or andexanet alfa
- Anticipated stenting of cervical or intracranial artery within 12 hours
- Anticipated coronary angioplasty within 12 hours
Where in Germany
- Universitaetsklinikum Aachen AöRAachen, GermanyTaking people
- Klinikum Altenburger Land GmbHAltenburg, GermanyTaking people
- Kamillus Klinik Asbach gGmbHAsbach, GermanyTaking people
- Klinikum Aschaffenburg-Alzenau gGmbHAschaffenburg, GermanyTaking people
- Universitaetsklinikum AugsburgAugsburg, GermanyTaking people
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbHBochum, GermanyTaking people
- Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
- Gesundheit Nord gGmbH Klinikverbund BremenBremen, GermanyTaking people
- Klinikum Chemnitz gGmbHChemnitz, GermanyTaking people
- Klinikum Dortmund gGmbHDortmund, GermanyTaking people
- Technische Universitaet DresdenDresden, GermanyTaking people
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, GermanyTaking people
- Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people
- Klinikum Frankfurt Hoechst GmbHFrankfurt Am Main, GermanyTaking people
- Martha-Maria Krankenhaus Halle-Doelau gGmbHHalle (saale), GermanyTaking people
- Asklepios Kliniken Hamburg GmbHHamburg, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Katholische Hospitalvereinigung Weser-Egge gGmbHHoexter, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people
- Universitaet LeipzigLeipzig, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRLuebeck, GermanyTaking people
- Staedtisches Klinikum Lueneburg gGmbHLueneburg, GermanyTaking people
- Otto Von Guericke Universitaet MagdeburgMagdeburg, GermanyTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyTaking people
- Heidelberg UniversityMannheim, GermanyTaking people
- Philipps-Universitaet MarburgMarburg, GermanyTaking people
- Evangelisches Krankenhaus Mettmann GmbHMettmann, GermanyTaking people
- Muehlenkreiskliniken AöRMinden, GermanyTaking people
- Kliniken Maria Hilf GmbH MoenchengladbachMoenchengladbach, GermanyTaking people
- Universitaet MuensterMuenster, GermanyTaking people
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, GermanyTaking people
- LMU Klinikum Muenchen AöRMunich, GermanyTaking people
- Klinikum NuernbergNuremberg, GermanyTaking people
- Evangelische Krankenhausstiftung OldenburgOldenburg, GermanyTaking people
- Klinikum Osnabrueck GmbHOsnabrueck, GermanyTaking people
- Klinikum Ernst von Bergmann gGmbHPotsdam, GermanyTaking people
- Universitaetsklinikum Regensburg AöRRegensburg, GermanyTaking people
- Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgart, GermanyTaking people
- Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbHWiesbaden, GermanyTaking people
- Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyTaking people
About the trial
What the trial wants to find out
To assess whether intravenous thrombolysis with tenecteplase 0.25 mg/kg improves functional outcome after acute ischemic stroke in patients taking direct oral anticoagulants compared to placebo.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants – a multicentre randomised placebo-controlled clinical trial
- Plain-language title
- Tenecteplase for stroke in people already taking blood-thinning tabletsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 28 September 2026