The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
NCT Number: NCT07168278
The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. The main question it aims to answer is: Does tenectplase improve the 90-days functional outcome in participants with acute large vessel occlusion? Researchers will compare tenectplase thrombolysis to non-use to see if tenectplase works to improve the functional outcome in participants with onset 4.5-9 hours. Participants will:* Receive 0.25mg/kg (max 25mg) tenectplase at admission (after randomization) .* Receive neurological assessment at admission, Day 5-7 or on hospital discharge (whichever earlier). Audio or video of the assessment may be recorded if possible.* Receive brain CT + CT angiogram + CT perfusion and MRI after randomization, where the CT scan may be repetitive.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
Hefei, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a dose of 0.25 mg/kg (max 25 mg) administered as a bolus
Other names: tenecteplase
antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.
Other names: standard treatment
Time frame: 90 days after procedure
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Time frame: 90 days after procedure
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
Time frame: 90 days after procedure
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Time frame: 24 hours after randomization
It specifically measures the mechanical success of recanalization at the site of the original occlusion.The scale ranges from 0 to 3, with higher scores indicating better recanalization. Grade 0: No recanalization (persistent occlusion). Grade 1: Incomplete recanalization (partial reopening with minimal flow). Grade 2: Partial recanalization (significant flow but residual stenosis or thrombus). Grade 3: Complete recanalization (full restoration of flow with no residual occlusion).
Time frame: Baseline and 7-days after randomization (or at discharge)
Zero indicates no stroke symptoms, 1-4 , 5-15, 16-20, 21-42 indicate minor, moderate, moderate to severe, and severe stroke, respectively.
Time frame: within 36 hours after randomization
SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 24 hours , or any hemorrhage leading to death.
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital of University of Science and Technology of China
Other
Tenecteplase vs Medical Management in 4.5-24h Anterior Circulation Large Vessel Occlusion With no Access to EVT
Acronym: TNK LATE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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