Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants
Key facts
- 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 és Wuerzburg, NémetországSee the 42 sites
- Phase
- 3. fázis
Where in Németország
- Universitaetsklinikum Aachen AöRAachen, NémetországTaking people
- Klinikum Altenburger Land GmbHAltenburg, NémetországTaking people
- Kamillus Klinik Asbach gGmbHAsbach, NémetországTaking people
- Klinikum Aschaffenburg-Alzenau gGmbHAschaffenburg, NémetországTaking people
- Universitaetsklinikum AugsburgAugsburg, NémetországTaking people
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországTaking people
- Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbHBochum, NémetországTaking people
- Universitaetsklinikum Bonn AöRBonn, NémetországTaking people
- Gesundheit Nord gGmbH Klinikverbund BremenBremen, NémetországTaking people
- Klinikum Chemnitz gGmbHChemnitz, NémetországTaking people
- Klinikum Dortmund gGmbHDortmund, NémetországTaking people
- Technische Universitaet DresdenDresden, NémetországTaking people
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, NémetországTaking people
- Universitaetsklinikum Erlangen AöRErlangen, NémetországTaking people
- Klinikum Frankfurt Hoechst GmbHFrankfurt Am Main, NémetországTaking people
- Martha-Maria Krankenhaus Halle-Doelau gGmbHHalle (saale), NémetországTaking people
- Asklepios Kliniken Hamburg GmbHHamburg, NémetországTaking people
- University Medical Center Hamburg-EppendorfHamburg, NémetországTaking people
- Medizinische Hochschule HannoverHanover, NémetországTaking people
- Katholische Hospitalvereinigung Weser-Egge gGmbHHoexter, NémetországTaking people
- Universitaetsklinikum Schleswig-Holstein AöRKiel, NémetországTaking people
- Universitaet LeipzigLeipzig, NémetországTaking people
- Universitaetsklinikum Schleswig-Holstein AöRLuebeck, NémetországTaking people
- Staedtisches Klinikum Lueneburg gGmbHLueneburg, NémetországTaking people
- Otto Von Guericke Universitaet MagdeburgMagdeburg, NémetországTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, NémetországTaking people
- Heidelberg UniversityMannheim, NémetországTaking people
- Philipps-Universitaet MarburgMarburg, NémetországTaking people
- Evangelisches Krankenhaus Mettmann GmbHMettmann, NémetországTaking people
- Muehlenkreiskliniken AöRMinden, NémetországTaking people
- Kliniken Maria Hilf GmbH MoenchengladbachMoenchengladbach, NémetországTaking people
- Universitaet MuensterMuenster, NémetországTaking people
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, NémetországTaking people
- LMU Klinikum Muenchen AöRMunich, NémetországTaking people
- Klinikum NuernbergNuremberg, NémetországTaking people
- Evangelische Krankenhausstiftung OldenburgOldenburg, NémetországTaking people
- Klinikum Osnabrueck GmbHOsnabrueck, NémetországTaking people
- Klinikum Ernst von Bergmann gGmbHPotsdam, NémetországTaking people
- Universitaetsklinikum Regensburg AöRRegensburg, NémetországTaking people
- Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgart, NémetországTaking people
- Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbHWiesbaden, NémetországTaking people
- Universitaetsklinikum Wuerzburg AöRWuerzburg, NémetországTaking people
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?
Trial details
- Who runs it
- University Medical Center Hamburg-Eppendorf
- Trial code
- EU 2025-521762-99-00
- Record updated
- 2026. szeptember 28.
- Original description
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.Read full original descriptionShow less
Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants – a multicentre randomised placebo-controlled clinical trial
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.
Inclusion: 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.
Exclusion: 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.