Tenecteplase
Drugintravenous tenecteplase (0.25 mg/kg, a single bolus over 5 to 10 seconds, a maximum of 25 mg).
NCT Number: NCT06010628
To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Hui-Sheng Chen, Shenyang, None Selected, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intravenous tenecteplase (0.25 mg/kg, a single bolus over 5 to 10 seconds, a maximum of 25 mg).
Time frame: 90±7 days
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time frame: 90±7 days
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time frame: 90±7 days
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time frame: 24 (-6/+12) hours
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Time frame: 10±2 days
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Time frame: 24 (-6/+12) hours
ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score
Time frame: 90±7 days
Time frame: 90±7 days
Time frame: 24 (-6/+12) hours
sICH is defined as parenchymal hematoma type 1 or 2 (PH1 or PH2), remote intraparenchymal hematoma (RIH), subarachnoid hemorrhage, or intraventricular hemorrhage on head CT/MRI scan causally associated with clinically significant neurological deterioration (NIHSS score ≥4 point increase) in the opinion of the clinical investigator or independent safety monitor.
Time frame: 24 (-6/+12) hours
any evidence of bleeding on the head CT scan, classified by the Heidelberg Bleeding Classification
Time frame: 24 (-6/+12) hours
Time frame: 24 (-6/+12) hours
General Hospital of Shenyang Military Region
Other
Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2): a Prospective, Randomized, Open Label, Blinded Endpoint, and Multi-center Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT06479174
Behavior, Brain Diseases
Albuquerque, New Mexico, United States
View Trial DetailsNCT06127602
Brain Diseases, Cardiovascular Diseases
Chicago, Illinois, United States
View Trial DetailsNCT07379190
Brain Diseases, Brain Infarction
Weifang, China/Shandong Province, China
View Trial DetailsNCT04078373
Brain Diseases, Cardiovascular Diseases
Ljubljana, Slovenia
View Trial Details