Tenecteplase for Acute ischemic stroke

Inclusion criteria

• {"criterion_text":"- Patients with acute ischemic stroke due to large vessel occlusion of the anterior circulation (distal ICA, Carotid-T, M1 or proximal M2 occlusion) should be confirmed by either CT or MRI and must be proven by catheter angiographic run prior to mechanical recanalization."}
• {"criterion_text":"- Successful recanalization (eTICI≥ 2b50) of intracranial artery occlusion (as per definition by the interventionalist)."}
• {"criterion_text":"- Estimated time between stroke onset / last seen well and study procedure of < 24 hours"}
• {"criterion_text":"- No relevant pre-stroke functional disability (pre-morbid mRS of 0 – 1)"}
• {"criterion_text":"- Neurological deficit with a NIHSS of ≥ 4 and ≤ 25 at baseline prior to thrombectomy"}
• {"criterion_text":"- Age ≥ 18"}
• {"criterion_text":"- ASPECTS ≥ 6 on baseline non-contrast CT or ASPECTS ≥ 5 on diffusion weighted MRI"}

Exclusion criteria

• {"criterion_text":"- Treatment with intravenous rt-pA (alteplase) thrombolysis at study site or intravenous TNK (tenecteplase) within 1 h before randomization"}
• {"criterion_text":"- Participating in another clinical trial that could confound the treatment or outcomes of this investigation"}
• {"criterion_text":"- Hypersensitivity to the active substance (Tenecteplase), to any other excipients or to gentamicin or know allergy against alteplase"}
• {"criterion_text":"- Pre-existing stenosis in the target vessel requiring stent therapy"}
• {"criterion_text":"- Tandem occlusions of both cervical and intracranial vessels"}
• {"criterion_text":"- Acute or prior intracranial hemorrhage or signs of intracranial hemorrhage during procedure"}
• {"criterion_text":"- Notably increased risk of intracranial hemorrhage"}
• {"criterion_text":"- Dissection of the extra- or intracranial cerebral arteries"}
• {"criterion_text":"- Major surgery or any severe bleeding in the past month"}
• {"criterion_text":"- Thrombocytopenia (Platelet count < 100,000)"}
• {"criterion_text":"- Insufficient command of the German language, if this can be reliably determined prior to enrolment."}
• {"criterion_text":"- Non-controlled hypertension (defined as SBP >185 mmHg or DBP >110 mmHg refractory to treatment)"}
• {"criterion_text":"- Pregnant or breast-feeding women"}
• {"criterion_text":"- Known severe illness with life expectancy less than 12 months"}

Primary endpoints

• {"endpoint_text":"- To investigate whether supplementary intra-arterial administration of thrombolysis (Tenecteplase) after successful endovascular recanalization of anterior circulation ischemic stroke results in improved clinical outcome evaluated based on the proportion of patients with an excellent clinical outcome of mRS 0 – 1 after 90 days +/- 15 days","definition_or_measurement_approach":"Proportion of patients with an excellent clinical outcome defined as mRS 0–1 at 90 days (±15 days)."}

Secondary endpoints

• {"endpoint_text":"- To investigate whether supplementary intra-arterial administration of thrombolysis (Tenecteplase) after successful endovascular recanalization of anterior circulation ischemic stroke results in improved recanalization grade, clinical outcome, neurological symptoms, performance in activities of daily living, cognitive status and quality of life evaluated on the basis of • the proportion of patients with a very good clinical outcome of mRS of 0 – 2 after 90 +/- 15 days","definition_or_measurement_approach":"Proportion of patients with mRS 0–2 at 90 days (±15 days); includes measures of recanalization grade, neurological symptoms, ADLs, cognition and quality of life."}
• {"endpoint_text":"- shift in mRS after 90 days","definition_or_measurement_approach":"Ordinal shift analysis of modified Rankin Scale at 90 days."}
• {"endpoint_text":"- absolute change in NIHSS at 24+/- 6h postrandomization","definition_or_measurement_approach":"Absolute change in NIHSS score measured at 24 (±6) hours post-randomization compared to baseline."}
• {"endpoint_text":"- normalized change in NIHSS at 24+/- 6h postrandomization","definition_or_measurement_approach":"Normalized change in NIHSS at 24 (±6) hours post-randomization (method not further specified in source)."}
• {"endpoint_text":"- EQ-5D-5L score after 90 +/- 15 days","definition_or_measurement_approach":"EQ-5D-5L health-related quality of life score at 90 days (±15 days)."}
• {"endpoint_text":"- MoCA after 90 +/- 15 days","definition_or_measurement_approach":"Montreal Cognitive Assessment (MoCA) score at 90 days (±15 days)."}
• {"endpoint_text":"- infarct volume (exploratory)","definition_or_measurement_approach":"Infarct volume measured (exploratory); specific imaging/measurement approach not detailed in the provided source."}

Germany

Earliest CTIS Part Ii Submission Date

08-10-2025

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

202

Number Of Sites

15

Number Of Participants

380

Primary sponsor

Full Name

Universitaetsklinikum Heidelberg AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Universitaetsklinikum Heidelberg AöR","duties_or_roles":"codes: 1,10,12,5,6,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Universitaetsklinikum Heidelberg AöR","duties_or_roles":"codes: 14","organisation_type":"Hospital/Clinic/Other health care facility"}