Clinical trial • Cardiology|Neurology
TENECTEPLASE for Acute ischemic stroke
Clinical trial of TENECTEPLASE for Acute ischemic stroke.
Overview
- Trial Therapeutic Area
- Cardiology|Neurology
- Trial Disease
- Acute ischemic stroke
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 01-10-2025
- First CTIS Authorization Date
- 16-12-2025
Trial design
Randomised, placebo to metalyse® (placebo comparator); metalyse (tenecteplase) 0.25 mg/kg iv (test drug), single intravenous administration (product also available as metalyse 5 000 units (25 mg) powder for solution for injection).-controlled trial in Germany.
- Randomised
- Yes
- Comparator
- Placebo to Metalyse® (placebo comparator); Metalyse (tenecteplase) 0.25 mg/kg IV (test drug), single intravenous administration (product also available as Metalyse 5 000 units (25 mg) powder for solution for injection).
- Target Sample Size
- 668
- Trial Duration For Participant
- 90
Eligibility
Recruits 668 Vulnerable population selected. Subject information and informed consent forms include patient forms and separate legal representative forms and subsequent consent forms (documents listed: L1_DE_SISandICF_Patient_de_redacted; L1_DE_SISandICF_Legal Representative_de_redacted; L1_DE_SISandICF_Patient_Subsequent Consent_de_redacted; L1_DE_SISandICF_Legal Representative_Subsequent Consent_de_redacted; L1_DE_SISandICF_Investigator Art 35 CTR_de_redacted). Consent may be obtained from the patient or, if the patient is unable, from a legal representative; subsequent consent procedures and investigator (Art 35 CTR) forms are provided..
- Vulnerable Population
- Vulnerable population selected. Subject information and informed consent forms include patient forms and separate legal representative forms and subsequent consent forms (documents listed: L1_DE_SISandICF_Patient_de_redacted; L1_DE_SISandICF_Legal Representative_de_redacted; L1_DE_SISandICF_Patient_Subsequent Consent_de_redacted; L1_DE_SISandICF_Legal Representative_Subsequent Consent_de_redacted; L1_DE_SISandICF_Investigator Art 35 CTR_de_redacted). Consent may be obtained from the patient or, if the patient is unable, from a legal representative; subsequent consent procedures and investigator (Art 35 CTR) forms are provided.
Inclusion criteria
- {"criterion_text":"- Age ≥ 18 years\n- Clinical diagnosis of acute stroke with disabling deficit\n- National Institutes of Health Stroke Scale (NIHSS) score at least 2\n- Recent intake (within 48 hours prior to enrolment) of a direct oral anticoagulant (apixaban, rivaroxaban, edoxaban, or dabigatran)\n- No evidence of any intracranial haemorrhage on cerebral imaging (CT or MRI) performed after stroke onset and no earlier than 60 minutes before enrolment\n- Stroke symptoms not known to have been present for > 6 h\n- 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 criteria
- {"criterion_text":"- Contraindication to intravenous thrombolysis, except DOAC therapy\n- Reversal or planned reversal of anticoagulation with idarucizumab or andexanet alfa\n- Concomitant therapy with antithrombotic medications, except DOACs\n- Anticipated stenting of cervical or intracranial artery within 12 hours\n- Anticipated coronary angioplasty within 12 hours\n- Any anticipated surgical intervention within 12 hours\n- Significant pre-stroke disability (mRS > 3)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Functional outcome (modified Rankin Scale, mRS) 90 days after randomisation","definition_or_measurement_approach":"Modified Rankin Scale (mRS) measured 90 days after randomisation to assess functional outcome."}
Secondary endpoints
- {"endpoint_text":"- Efficacy Endpoint: Nondisabled (mRS score ≤ 1) functional outcome after 90 days","definition_or_measurement_approach":"mRS score ≤ 1 at 90 days"}
- {"endpoint_text":"- Efficacy Endpoint: Independent (mRS score ≤ 2) functional outcome after 90 days","definition_or_measurement_approach":"mRS score ≤ 2 at 90 days"}
- {"endpoint_text":"- Efficacy Endpoint: Early neurological deficit (National Institutes of Health stroke scale) after 24 hours","definition_or_measurement_approach":"NIHSS score measured at 24 hours"}
- {"endpoint_text":"- Efficacy Endpoint: Health-related quality of life (PROMIS®-10) after 90 days","definition_or_measurement_approach":"PROMIS-10 instrument measured at 90 days"}
- {"endpoint_text":"- Efficacy Endpoint: Cognitive impairment (Montreal Cognitive Assessment) after 90 days","definition_or_measurement_approach":"Montreal Cognitive Assessment (MoCA) measured at 90 days"}
- {"endpoint_text":"- Safety Endpoint: Any intracranial haemorrhage within 36 hours","definition_or_measurement_approach":"Any intracranial haemorrhage occurring within 36 hours"}
- {"endpoint_text":"- Safety Endpoint: Symptomatic intracranial haemorrhage within 36 hours (mSITS-MOST)","definition_or_measurement_approach":"Symptomatic intracranial haemorrhage within 36 hours defined by mSITS-MOST criteria"}
- {"endpoint_text":"- Safety Endpoint: Fatal intracranial haemorrhage within 30 days","definition_or_measurement_approach":"Fatal intracranial haemorrhage occurring within 30 days"}
- {"endpoint_text":"- Safety Endpoint: Major haemorrhage (ISTH) within 72 hours","definition_or_measurement_approach":"Major haemorrhage as per ISTH criteria within 72 hours"}
- {"endpoint_text":"- Safety Endpoint: Orolingual angioedema within 4 hours","definition_or_measurement_approach":"Occurrence of orolingual angioedema within 4 hours"}
- {"endpoint_text":"- Safety Endpoint: Death or dependency (mRS score 4–6) after 90 days","definition_or_measurement_approach":"mRS score 4–6 at 90 days"}
- {"endpoint_text":"- Safety Endpoint: All-cause mortality after 90 days","definition_or_measurement_approach":"All-cause mortality measured at 90 days"}
- {"endpoint_text":"- Safety Endpoint: Time to death right-censored at 90 days","definition_or_measurement_approach":"Time to death endpoint with right censoring at 90 days"}
Recruitment
- Planned Sample Size
- 668
- Recruitment Window Months
- 49
- Consent Approach
- Informed consent provided by the participant; if the participant is unable to consent, a legal representative can provide consent. Subsequent consent forms are available (subsequent consent documents listed). Patient-facing and legal representative informed consent forms are provided (documents are in German as indicated by document titles with '_de'). Investigator Art 35 CTR consent documentation is also provided.
Geography
- Total Number Of Sites
- 34
- Total Number Of Participants
- 668
Germany
- Earliest CTIS Part Ii Submission Date
- 25-11-2025
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 97
- Number Of Sites
- 34
- Number Of Participants
- 668
Sites
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Michael Gliem
- Contact Person Email
- Michael.Gliem@med.uni-duesseldorf.de
- Site Name
- Klinikum Dortmund gGmbH
- Department Name
- Neurologische Klinik
- Contact Person Name
- Gernot Reimann
- Contact Person Email
- Gernot.Reimann@klinikumdo.de
- Site Name
- Klinikum Nuernberg
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Jan Liman
- Contact Person Email
- Jan.Liman@klinikum-nuernberg.de
- Site Name
- Staedtisches Klinikum Lueneburg gGmbH
- Department Name
- Klinik für Neurologie und Klinische Neurophysio-logie
- Contact Person Name
- Waltraud Pfeilschifter
- Contact Person Email
- Waltraud.pfeilschifter@klinikum-lueneburg.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Neurologie mit Klinischer Neurophysiologie
- Contact Person Name
- Ramona Schuppner
- Contact Person Email
- schuppner.ramona@mh-hannover.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Neurologische Klinik und Poliklinik
- Contact Person Name
- Christian Hametner
- Contact Person Email
- hametner_c@ukw.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Arno Reich
- Contact Person Email
- areich@ukaachen.de
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Klinik und Poliklinik für Neurologie
- Contact Person Name
- Silke Wunderlich
- Contact Person Email
- Silke.wunderlich@mri.tum.de
- Site Name
- Klinikum Aschaffenburg-Alzenau gGmbH
- Department Name
- Neurologische Klinik
- Contact Person Name
- Oliver Bähr
- Contact Person Email
- oliver.baehr@klinikum-ab-alz.de
- Site Name
- Katholische Hospitalvereinigung Weser-Egge gGmbH
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Mark Obermann
- Contact Person Email
- m.obermann@khwe.de
- Site Name
- Gesundheit Nord gGmbH Klinikverbund Bremen
- Department Name
- Neurologische Klinik
- Contact Person Name
- Andreas Kastrup
- Contact Person Email
- andreas.kastrup@gesundheitnord.de
- Site Name
- Klinikum Der Landeshauptstadt Stuttgart gKAöR
- Department Name
- Neurologische Klinik
- Contact Person Name
- Marc Wolf
- Contact Person Email
- ma.wolf@klinikum-stuttgart.de
- Site Name
- Evangelisches Krankenhaus Mettmann GmbH
- Department Name
- Akademisches Lehrkrankenhaus der Universität
- Contact Person Name
- Bert Bosche
- Contact Person Email
- b.bosche@evk-mettmann.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Klinik für Vaskuläre Neurologie
- Contact Person Name
- Gabor Petzold
- Contact Person Email
- Gabor.Petzold@ukbonn.de
- Site Name
- Klinikum Frankfurt Hoechst GmbH
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Thorsten Steiner
- Contact Person Email
- thorsten.steiner@varisano.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Neurologie mit Experimenteller Neurologie, Centrum für Schlaganfallforschung Berlin
- Contact Person Name
- Christian Nolte
- Contact Person Email
- christian.nolte@charite.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Klinik und Poliklinik für Neurologie
- Contact Person Name
- Eckhard Schlemm
- Contact Person Email
- e.schlemm@uke.de
- Site Name
- Klinikum Altenburger Land GmbH
- Department Name
- Klinik für Neurologie/ Neurologische Intensivmedizin
- Contact Person Name
- Jörg Berrouschot
- Contact Person Email
- joerg.berrouschot@klinikum-altenburgerland.de
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik für Neurologie
- Contact Person Name
- Dominik Michalski
- Contact Person Email
- Dominik.Michalski@medizin.uni-leipzig.de
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- Institut für Schlaganfall- und Demenzforschung
- Contact Person Name
- Martin Dichgans
- Contact Person Email
- Martin.Dichgans@med.uni-muenchen.de
- Site Name
- Heidelberg University
- Department Name
- Neurologische Klinik und Poliklinik
- Contact Person Name
- Carolin Hoyer
- Contact Person Email
- carolin.hoyer@umm.de
- Site Name
- HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Frank Arne Wollenweber
- Contact Person Email
- frank.wollenweber@helios-gesundheit.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Klinik und Poliklinik für Neurologie
- Contact Person Name
- Timo Uphaus
- Contact Person Email
- timo.uphaus@unimedizin-mainz.de
- Site Name
- Muehlenkreiskliniken AöR
- Department Name
- Universitätsklinik für Neurologie und Neurogeriatrie
- Contact Person Name
- Peter Schellinger
- Contact Person Email
- peter.schellinger@muehlenkreiskliniken.de
- Site Name
- Universitaet Muenster
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Antje Schmidt-Pogoda
- Contact Person Email
- antje.schmidt-pogoda@ukmuenster.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Universitätsklinik für Neurologie
- Contact Person Name
- Jens Neumann
- Contact Person Email
- jens.neumann@med.ovgu.de
- Site Name
- Evangelische Krankenhausstiftung Oldenburg
- Department Name
- Universitätsklinik für Neurologie
- Contact Person Name
- Thomas Liman
- Contact Person Email
- Thomas.Liman@uni-oldenburg.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Milani Deb-Chatterji
- Contact Person Email
- Milani.Deb-Chatterji@uksh.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Klinik und Poliklinik für Neurologie
- Contact Person Name
- Timo Siepmann
- Contact Person Email
- timo.siepmann@ukdd.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Neurologische Klinik
- Contact Person Name
- Stefan Gerner
- Contact Person Email
- stefan.gerner@uk-erlangen.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Campus Lübeck Klinik für Neurologie
- Contact Person Name
- Georg Royl
- Contact Person Email
- Georg.Royl@uksh.de
- Site Name
- Martha-Maria Krankenhaus Halle-Doelau gGmbH
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Frank Hoffmann
- Contact Person Email
- frank.hoffmann@martha-maria.de
- Site Name
- Philipps-Universitaet Marburg
- Department Name
- Klinik und Poliklinik für Neurologie
- Contact Person Name
- Anja Gerstner
- Contact Person Email
- gerstner@med.uni-marburg.de
- Site Name
- Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Ilka Kleffner
- Contact Person Email
- ilka.kleffner@knappschaft-kliniken.de
Sponsor
Primary sponsor
- Full Name
- University Medical Center Hamburg-Eppendorf
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Third parties
- {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"5","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"GKM Gesellschaft fuer Therapieforschung mbH","duties_or_roles":"1,12,5,8","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"14","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"10,6","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Boehringer Ingelheim Pharma GmbH & Co. KG","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Eppdata GmbH","duties_or_roles":"13","organisation_type":"Pharmaceutical company"}
Co-sponsors
- GKM Gesellschaft fuer Therapieforschung mbH
Investigational products
- Investigational Product Name
- Metalyse 5 000 units (25 mg) powder for solution for injection
- Active Substance
- TENECTEPLASE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- Intravenous injection
- Authorisation Status
- Marketing authorisation EU/1/00/169/007 (authorised)
- Starting Dose
- 0.25 mg/kg
- Dose Levels
- 0.25 mg/kg (maximum 25 mg)
- Frequency
- Single administration
- Maximum Dose
- 25 mg
- Investigational Product Name
- Placebo to Metalyse®
- Modality
- Other
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