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New treatment option for Acute Ischemic Stroke
Official title Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours
ClinicalTrials.gov ID: NCT07203625
What this study is testing
What is Tenecteplase thrombolysis?
Tenecteplase thrombolysis is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Also referred to as rhTNK-tPA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed to investigate the efficacy and safety of intravenous tenecteplase before interhospital transfer from a non-endovascular capable center(nECC) to an endovascular capable center (ECC) for thrombectomy in patients with acute ischemic stroke (AIS) caused by neuroimaging-confirmed acute basilar artery occlusion (BAO) between 4.5-24 hours of symptom onset.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years;
- Patients presenting with posterior circulation ischemic stroke symptoms due to BAO;
- BAO confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA);
- Time from AIS symptom onset to randomization within 4.5-24 hours, stroke onset is defined as the onset of acute symptoms leading to the clinical...
- Baseline National Institute of Health Stroke Scale (NIHSS) score obtained prior to randomization ≥6;
You likely can't join if
- Posterior Circulation Acute Stroke Prognosis Early CT score (PC-ASPECTS) \< 6 on computed tomography (CT)/CTA-Source Images/MRI with...
- CT/MR shows evidence of intracranial hemorrhage and tumor (except small meningioma)
- Complete cerebellar infarct on CT/MRI with significant mass effect and compression of the 4th ventricle
- Bilateral extensive brainstem infarction on CT/MRI
- Simultaneous occlusion of both anterior and posterior circulation confirmed by CTA/MRA/DSA (patients with a history of occlusion of anterior...
- Treatment with a thrombolytic within the last 72 hours or intention to receive intravenous thrombolysis
See the full eligibility criteria
- Age ≥18 years;
- Patients presenting with posterior circulation ischemic stroke symptoms due to BAO;
- BAO confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA);
- Time from AIS symptom onset to randomization within 4.5-24 hours, stroke onset is defined as the onset of acute symptoms leading to the clinical diagnosis of basilar artery occlusion (BAO) not considering the time of...
- Baseline National Institute of Health Stroke Scale (NIHSS) score obtained prior to randomization ≥6;
- Functionally independent (modified Rankin Scale [mRS] 0-2) prior to stroke onset;
- Intended to transfer for thrombectomy. Two paradigms are allowed in this study: (1)transferring patients to ECC (patient transfer); (2)travelling neurointerventionist to nECC (physician transfer);
- Written informed consent from patients or legally responsible representatives
- Posterior Circulation Acute Stroke Prognosis Early CT score (PC-ASPECTS) \< 6 on computed tomography (CT)/CTA-Source Images/MRI with diffusion-weighted imaging (DWI)
- CT/MR shows evidence of intracranial hemorrhage and tumor (except small meningioma)
- Complete cerebellar infarct on CT/MRI with significant mass effect and compression of the 4th ventricle
- Bilateral extensive brainstem infarction on CT/MRI
- Simultaneous occlusion of both anterior and posterior circulation confirmed by CTA/MRA/DSA (patients with a history of occlusion of anterior circulation more than three months ago can be included)
- Treatment with a thrombolytic within the last 72 hours or intention to receive intravenous thrombolysis
- Known hypersensitivity or allergy to any ingredients of Tenecteplase
- Any other contra-indication for intravenous thrombolysis except for the time criteria
- Known hereditary or acquired hemorrhagic diathesis
- Impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, international normalized ratio (INR) \>1.7 or prothrombin time \>15s; if use of any direct oral anticoagulant within the last 48...
- Ischemic stroke or myocardial infarction in previous 3 months
- Previous intracranial hemorrhage, active internal bleeding (gastrointestinal or urinary tract hemorrhage) in previous 3 months
- Severe, uncontrolled hypertension (systolic blood pressure \>185mmHg or diastolic blood pressure \>110mmHg)
- Baseline blood glucose \ 400mg/dl
- Baseline platelet count \<100,000/μL
- Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate \ 220mmol/L (2.5mg/dL)
- Known severe, life-threatening allergy (more severe than skin rash) to contrast agents
- Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery
- Known diagnosis or clinical suspicion of cerebral vasculitis
- Known diagnosis or clinical suspicion of endocarditis
- Pregnancy or lactating;
- Other serious, advanced or terminal illness with life expectancy less than 6 months
- Current participation in any investigational study that may confound outcome assessment of the study
- Any condition that, in the judgement of the investigator, is inappropriate for participation in the trial or could impose hazards to the patient (e.g. inability to understand and/or follow the study procedures and/or...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.