Clinical trial • Phase III • Neurology
TENECTEPLASE for Acute ischemic stroke
Phase III trial of TENECTEPLASE for Acute ischemic stroke.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Acute ischemic stroke
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 25-10-2024
- First CTIS Authorization Date
- 23-01-2025
Trial design
Factor Xa inhibitors (current standard of care): RIVAROXABAN (oral; product record shows max total dose 30 mg), APIXABAN (oral; product record shows max total dose 20 mg), EDOXABAN (oral; product record shows max total dose 60 mg).-controlled Phase III trial in Norway, Denmark, Sweden.
- Comparator
- Factor Xa inhibitors (current standard of care): RIVAROXABAN (oral; product record shows max total dose 30 mg), APIXABAN (oral; product record shows max total dose 20 mg), EDOXABAN (oral; product record shows max total dose 60 mg).
- Target Sample Size
- 500
- Trial Duration For Participant
- 90
Eligibility
Recruits 500 Vulnerable population selected. Subject information and informed consent forms are available for patients, next of kin and legal/professional legal representatives (documents listed: L1_ICF patients; L1_ICF next of kin; L1_ICF_Professional Legal Representative; L1_ICF_legal representative). Consent may be obtained from legal representatives/next of kin where applicable..
- Vulnerable Population
- Vulnerable population selected. Subject information and informed consent forms are available for patients, next of kin and legal/professional legal representatives (documents listed: L1_ICF patients; L1_ICF next of kin; L1_ICF_Professional Legal Representative; L1_ICF_legal representative). Consent may be obtained from legal representatives/next of kin where applicable.
Inclusion criteria
- {"criterion_text":"- Participant must be 18 years of age or older.\n- Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown)\n- Clinical diagnosis of AIS with disabling neurological deficit\n- Presenting within 4.5 h of symptom onset or after awakening with symptoms of AIS with FLAIR-DWI mismatch on MRI as judged by the (neuro-) radiologist.\n- Informed consent."}
Exclusion criteria
- {"criterion_text":"- Endovascular treatment eligible patients with isolated large vessel occlusion of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography and expected time from randomization to groin puncture of <30 minutes.\n- Systolic BP >185 mmHg or diastolic BP >110 mmHg despite antihypertensive treatment\n- Known bleeding diathesis; manifest or recent severe bleeding; significant bleeding disorder last 6 months.\n- Arterial puncture at a noncompressible site; biopsy or lumbar puncture <7 days; major surgery, traumatic external heart massage, obstetrical delivery or serious trauma <14 days; history of intracranial haemorrhage; stroke <2 months, CNS neurosurgery <2 months; serious head trauma <2 months; pericarditis; sepsis; bacterial endocarditis; pericarditis; acute pancreatitis; neoplasm with increased bleeding risk; any serious medical illness likely to interact with treatment (i.e. aortic dissection); confounding pre-existent neurological or psychiatric disease.\n- Any condition that, in the opinion of the treating physician, puts a patient at risk if treated with thrombolysis (i.e. signs of cerebral hemorrhage, known cerebral amyloid angiopathy, CT with signs of early ischemia greater than one-third of the middle cerebral artery territory)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Early neurological improvement, defined as a reduction of ≥8 points on the National Institutes of Health Stroke Scale (NIHSS), or NIHSS of 0-1 at 24 hours ± 12.","definition_or_measurement_approach":"Defined as a reduction of ≥8 points on the National Institutes of Health Stroke Scale (NIHSS), or NIHSS of 0-1 measured at 24 hours ± 12 hours."}
Secondary endpoints
- {"endpoint_text":"- Percentage change in NIHSS from baseline to 24 h ± 12 h.","definition_or_measurement_approach":"Percentage change in NIHSS from baseline to 24 hours ± 12 hours."}
- {"endpoint_text":"- Percent change in infarct volume at 24 h ± 12 hours.","definition_or_measurement_approach":"Percent change in infarct volume measured by CT/MRI at 24 hours ± 12 hours."}
- {"endpoint_text":"- Proportion of patients: - obtaining a good functional outcome (mRS 0-2) at day 90 (+/- 2weeks); obtaining an excellent functional outcome (mRS 0-1) at day 90 (+/- 2 weeks); mRS category at day 90 (+/- 2 weeks).","definition_or_measurement_approach":"Functional outcome measured by modified Rankin Scale (mRS) at day 90 (± 2 weeks): proportions achieving mRS 0-2 and mRS 0-1 and distribution of mRS categories."}
- {"endpoint_text":"- Occurrence of sICH on CT/MRI within 36 hours post IVT causally related to an increase of 4 points or more on the NIHSS.","definition_or_measurement_approach":"Symptomatic intracerebral hemorrhage (sICH) on CT/MRI within 36 hours after IV thrombolysis, defined as radiographic ICH causally related to an increase of ≥4 points on the NIHSS."}
- {"endpoint_text":"- Any ICH on CT/MR within 36 hours post IVT.","definition_or_measurement_approach":"Any intracerebral hemorrhage detected on CT or MRI within 36 hours after IV thrombolysis."}
- {"endpoint_text":"- Occurrence of death within 90 days.","definition_or_measurement_approach":"All-cause mortality assessed up to 90 days after treatment."}
Recruitment
- Planned Sample Size
- 500
- Recruitment Window Months
- 97
- Consent Approach
- Informed consent is required. Subject information and informed consent forms are available for patients and for next of kin/legal representatives (documents listed in the record: L1_ICF patients; L1_ICF next of kin; L1_ICF_Professional Legal Representative; L1_ICF_legal representative). The presence of legal representative/next-of-kin ICFs indicates consent procedures for incapacitated participants via legal representatives; no languages or age-specific assent details are specified in the record.
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 500
Norway
- Earliest CTIS Part Ii Submission Date
- 15-01-2025
- Latest Decision Or Authorization Date
- 10-03-2025
- Processing Time Days
- 54
- Number Of Sites
- 13
- Number Of Participants
- 300
Sites
- Site Name
- Haraldsplass Diakonale Sykehus AS
- Department Name
- Department of Medicine
- Principal Investigator Name
- Paal Naalsud
- Principal Investigator Email
- paal.naalsund@haraldsplass.no
- Contact Person Name
- Paal Naalsud
- Contact Person Email
- paal.naalsund@haraldsplass.no
- Site Name
- Vestre Viken HF
- Department Name
- Medical department
- Principal Investigator Name
- Håkon Ihle-Hansen
- Principal Investigator Email
- haaihl@vestreviken.no
- Contact Person Name
- Håkon Ihle-Hansen
- Contact Person Email
- haaihl@vestreviken.no
- Site Name
- St. Olavs Hospital HF
- Department Name
- Department of Stroke
- Principal Investigator Name
- Fredrik Ildstad
- Principal Investigator Email
- Fredrik.Ildstad@stolav.no
- Contact Person Name
- Fredrik Ildstad
- Contact Person Email
- Fredrik.Ildstad@stolav.no
- Site Name
- University Hospital of North Norway
- Department Name
- Department of Neurology
- Principal Investigator Name
- Agnethe Eltoft
- Principal Investigator Email
- Agnethe.Eltoft@unn.no
- Contact Person Name
- Agnethe Eltoft
- Contact Person Email
- Agnethe.Eltoft@unn.no
- Site Name
- Haukeland University Hospital
- Department Name
- Department of Neurology
- Principal Investigator Name
- Annette Fromm
- Principal Investigator Email
- annette.fromm@helse-bergen.no
- Contact Person Name
- Annette Fromm
- Contact Person Email
- annette.fromm@helse-bergen.no
- Site Name
- Sykehuset I Vestfold HF
- Department Name
- Department of Neurology
- Principal Investigator Name
- Håvard Lisether
- Principal Investigator Email
- haalis@siv.no
- Contact Person Name
- Håvard Lisether
- Contact Person Email
- haalis@siv.no
- Site Name
- Helse Møre and Romsdal Health Trust
- Department Name
- Geriatrician/internal medicine
- Principal Investigator Name
- Yngve Müller Seljeseth
- Principal Investigator Email
- postmottak@helse-mr.no
- Contact Person Name
- Yngve Müller Seljeseth
- Contact Person Email
- postmottak@helse-mr.no
- Site Name
- Sykehuset Innlandet
- Department Name
- Neurological department
- Principal Investigator Name
- Anette Huse Farmen
- Principal Investigator Email
- Anette.Huuse.Farmen@sykehuset-innlandet.no
- Contact Person Name
- Anette Huse Farmen
- Contact Person Email
- Anette.Huuse.Farmen@sykehuset-innlandet.no
- Site Name
- Helse Stavanger HF
- Department Name
- Department of Neurology
- Principal Investigator Name
- Soffien Ajmi
- Principal Investigator Email
- soffien.chadli.ajmi@sus.no
- Contact Person Name
- Soffien Ajmi
- Contact Person Email
- soffien.chadli.ajmi@sus.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Neurology
- Principal Investigator Name
- Vojtech Novotny
- Principal Investigator Email
- vojnov@ous-hf.no
- Contact Person Name
- Vojtech Novotny
- Contact Person Email
- vojnov@ous-hf.no
- Site Name
- Drammen Sykehus
- Department Name
- Department of Neurology
- Principal Investigator Name
- Kristin Evensen
- Principal Investigator Email
- SBEVEK@vestreviken.no
- Contact Person Name
- Kristin Evensen
- Contact Person Email
- SBEVEK@vestreviken.no
- Site Name
- Østfold Hospital Trust
- Department Name
- Department of Neurology
- Principal Investigator Name
- Barbara Ratajczak-Tretel
- Principal Investigator Email
- Barbara.Ratajczak@so-hf.no
- Contact Person Name
- Barbara Ratajczak-Tretel
- Contact Person Email
- Barbara.Ratajczak@so-hf.no
- Site Name
- Hospital of Southern Norway, Kristiansand
- Department Name
- Department of Neurology
- Principal Investigator Name
- Mary-Helen Soyland
- Principal Investigator Email
- mary-helen.soyland@sshf.no
- Contact Person Name
- Mary-Helen Soyland
- Contact Person Email
- mary-helen.soyland@sshf.no
Denmark
- Earliest CTIS Part Ii Submission Date
- 11-03-2026
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 7
- Number Of Sites
- 9
- Number Of Participants
- 100
Sites
- Site Name
- Sygehus Lillebælt, Region Syddanmark
- Department Name
- Hjerne- og Nervesygdomme
- Principal Investigator Name
- Henrik Boye Jensen
- Principal Investigator Email
- Henrik.Boye.Jensen@rsyd.dk
- Contact Person Name
- Henrik Boye Jensen
- Contact Person Email
- Henrik.Boye.Jensen@rsyd.dk
- Site Name
- Rigshospitalet
- Department Name
- Neurologisk Afdeling
- Principal Investigator Name
- Thomas Clement Truelsen
- Principal Investigator Email
- thomas.clement.truelsen@regionh.dk
- Contact Person Name
- Thomas Clement Truelsen
- Contact Person Email
- thomas.clement.truelsen@regionh.dk
- Site Name
- Odense Universitetshospital
- Department Name
- Neurologisk Afdeling
- Principal Investigator Name
- Alex Alban Christensen
- Principal Investigator Email
- Alex.Alban.Christensen@rsyd.dk
- Contact Person Name
- Alex Alban Christensen
- Contact Person Email
- Alex.Alban.Christensen@rsyd.dk
- Site Name
- Aarhus Universitethospital
- Department Name
- Neurologisk Afdeling
- Principal Investigator Name
- Rolf Blauenfeldt
- Principal Investigator Email
- rolfblau@rm.dk
- Contact Person Name
- Rolf Blauenfeldt
- Contact Person Email
- rolfblau@rm.dk
- Site Name
- Sjællands Universitetshospital
- Department Name
- Neurologisk Afdeling
- Principal Investigator Name
- Troels Wienecke
- Principal Investigator Email
- trw@regionsjaelland.dk
- Contact Person Name
- Troels Wienecke
- Contact Person Email
- trw@regionsjaelland.dk
- Site Name
- Bispebjerg Hospital, Region Hovedstaden
- Department Name
- Neurologisk Afdeling
- Principal Investigator Name
- Louisa Marguerite Christensen
- Principal Investigator Email
- louisa.marguerite.christensen@regionh.dk
- Contact Person Name
- Louisa Marguerite Christensen
- Contact Person Email
- louisa.marguerite.christensen@regionh.dk
- Site Name
- Regionshospitalet Gødstrup
- Department Name
- Neurologisk Afdeling
- Principal Investigator Name
- Anne Brink Behrndtz
- Principal Investigator Email
- annebrin@rm.dk
- Contact Person Name
- Anne Brink Behrndtz
- Contact Person Email
- annebrin@rm.dk
- Site Name
- Sygehus Sønderjylland, Aabenraa
- Department Name
- Afdeling for Hjerne- og Nervesygdomme
- Principal Investigator Name
- Sepehr Mamoei
- Principal Investigator Email
- Sepehr.Mamoei@rsyd.dk
- Contact Person Name
- Sepehr Mamoei
- Contact Person Email
- Sepehr.Mamoei@rsyd.dk
- Site Name
- Aalborg Universitetshospital
- Department Name
- Neurologisk Afdeling
- Principal Investigator Name
- Daniel Harsfort
- Principal Investigator Email
- d.harsfort@rn.dk
- Contact Person Name
- Daniel Harsfort
- Contact Person Email
- d.harsfort@rn.dk
Sweden
- Earliest CTIS Part Ii Submission Date
- 11-02-2026
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 19
- Number Of Sites
- 6
- Number Of Participants
- 100
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Neurologi
- Principal Investigator Name
- Boris Keselmann
- Principal Investigator Email
- boris.keselman@regionstockholm.se
- Contact Person Name
- Boris Keselmann
- Contact Person Email
- boris.keselman@regionstockholm.se
- Site Name
- Region Skane Skanes Universitetssjukhus (Malmo St. Johns)
- Department Name
- Neurologi
- Principal Investigator Name
- Fredrik Buchwald
- Principal Investigator Email
- fredrik.buchwald@skane.se
- Contact Person Name
- Fredrik Buchwald
- Contact Person Email
- fredrik.buchwald@skane.se
- Site Name
- Norrlands universitetssjukhus
- Department Name
- Neuro-huvud-halscentrum
- Principal Investigator Name
- Johan Birnefeld
- Principal Investigator Email
- johan.birnefeld@umu.se
- Contact Person Name
- Johan Birnefeld
- Contact Person Email
- johan.birnefeld@umu.se
- Site Name
- Uppsala University Hospital
- Department Name
- Medicinkliniken
- Principal Investigator Name
- Karl Sjölin
- Principal Investigator Email
- karl.sjolin@akademiska.se
- Contact Person Name
- Karl Sjölin
- Contact Person Email
- karl.sjolin@akademiska.se
- Site Name
- Danderyds Sjukhus AB
- Department Name
- Neurologiska
- Principal Investigator Name
- Sara Jadidi
- Principal Investigator Email
- sara.jadidi@regionstockholm.se
- Contact Person Name
- Sara Jadidi
- Contact Person Email
- sara.jadidi@regionstockholm.se
- Site Name
- Region Skane Skanes Universitetssjukhus (Lund)
- Department Name
- Neurologi
- Principal Investigator Name
- Gunnar Andsberg
- Principal Investigator Email
- gunnar.andsberg@skane.se
- Contact Person Name
- Gunnar Andsberg
- Contact Person Email
- gunnar.andsberg@skane.se
Sponsor
Primary sponsor
- Full Name
- Oslo University Hospital HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- TENECTEPLASE
- Active Substance
- TENECTEPLASE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Maximum Dose
- 25 mg
- Investigational Product Name
- ALTEPLASE
- Active Substance
- ALTEPLASE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Maximum Dose
- 90 mg
- Investigational Product Name
- RIVAROXABAN
- Active Substance
- RIVAROXABAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 30 mg
- Investigational Product Name
- APIXABAN
- Active Substance
- APIXABAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 20 mg
- Investigational Product Name
- EDOXABAN
- Active Substance
- EDOXABAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 60 mg
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