TRACE-5Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5 Improving Neurological Functional Outcomes in Basilar Artery Occlusion With Tenecteplase in Extended Time Window: Multicentre, Prospective, Open-label, Blinded Endpoint (PROBE), Phase 3, Randomized Controlled Trial
Tenecteplase
+ Best Practice (which may include intravenous Alteplase)
Ischemic Stroke+5
+ Brain Diseases
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: January 24, 2024
Actual date on which the first participant was enrolled.This study focuses on patients who have experienced a type of stroke called acute ischemic stroke, specifically when it's caused by a blockage in the basilar artery, a major blood vessel in the brain. The study aims to see if a drug called tenecteplase can improve recovery when given up to 24 hours after symptoms start. These strokes can lead to serious problems, so finding effective treatments is important to help patients recover better and reduce long-term impacts. In this trial, participants will be randomly assigned to receive either the usual care, which may include a drug called alteplase within 4.5 hours of stroke onset, or tenecteplase through an injection into the vein. The study will monitor how well patients recover their neurological functions after receiving these treatments. Doctors will use imaging tests like CT or MRI to confirm the blockage in the artery and decide if the clot can potentially be removed. The results will help determine if tenecteplase is a better option for treating this type of stroke, especially when given after the usual treatment window.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.452 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Age ≥18. 2. Patients presenting with posterior circulation ischemic stroke symptoms due to near-complete or complete basilar artery occlusion within 24 hours from symptom onset (or clinical deterioration/coma) or the time the patient was last known to be well. 3. Presence of a basilar artery occlusion, proven by CT Angiography or MR Angiography. Basilar artery occlusion will be defined as 'potentially retrievable' occlusion at the basilar artery. This can be a near or complete occlusion. 4. Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week). 5. Local legal requirements for consent have been satisfied. Exclusion Criteria: 1. Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging. 2. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) \<6 on non-contrast CT (NCCT) or CTA-source images or MRI diffusion weighted imaging (DWI). 3. Significant cerebellar mass effect or acute hydrocephalus. 4. Established frank hypodensity on non-contrast CT indicating subacute infarction. 5. Bilateral extensive brainstem ischemia. 6. Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability). 7. Other standard contraindications to intravenous thrombolysis. 8. Contraindication to imaging with contrast agents. 9. Clinically evident pregnant women. 10. Vessel imaging showing both anterior and posterior circulation large vessel occlusion. 11. Current participation in another research drug treatment protocol. 12. Known terminal illness such that the patients would not be expected to survive a year. 13. Planned withdrawal of care or comfort care measures. 14. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 59 locations
Beijing Daxing District People's Hospital
Beijing, ChinaOpen Beijing Daxing District People's Hospital in Google MapsTaihe County Traditional Chinese Medicine Hospital
Fuyang, ChinaLixin County People's Hospital
Haozhou, ChinaBeijing Tian Tan Hospital, Capital Medical University
Beijing, China