Acute Ischemic StrokePhase 4OPTION-2NCT07203625
Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours
A Phase 4 study testing Tenecteplase thrombolysis in people with Acute Ischemic Stroke and Basilar Artery Occlusion, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Basilar Artery Occlusion
- What is being tested?
- Tenecteplase thrombolysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 31 Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 any preceding minor prodromal symptoms (such as isolated vertigo, diplopia or sensory changes) as onset time or, if not known, the time the patient was last known to be well (including wake-up stroke and unwitnessed stroke);
- 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
Who cannot join
- 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
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- 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 hours; if use of heparin/heparinoid within the last 24 hours
- 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 <50mg/dl or >400mg/dl
- Baseline platelet count <100,000/μL
- Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate <30mL/min or serum creatinine >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 follow-up due to mental disorders, cognitive or emotional disorders)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing
Gaoting Ma, MD, 010-83198082, demo_doctor@163.com
About this study
Official title: Intravenous Tenecteplase Before Interhospital Transfer for Thrombectomy in Acute Basilar Artery Occlusion at 4.5 to 24 Hours
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.
Read the detailed description
This is a multicenter, prospective, open-label, blinded endpoint (PROBE), randomized controlled trial in patients with acute ischemic stroke due to BAO first presenting to a nECC and intending to undertake thrombectomy in an ECC.
Patients will be required to have occlusion of the basilar artery on baseline computed tomography angiography (CTA)/magnetic resonance angiography (MRA) at the nECC. Patients will be randomized to either intravenous tenecteplase (0.25mg/kg, maximum 25mg)or not before interhospital transfer.
- Conditions
- Acute Ischemic Stroke, Basilar Artery Occlusion
- Being tested
- Tenecteplase thrombolysis
- Keywords
- basilar artery occlusion, thrombolysis, interhospital transfer
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenecteplase thrombolysisDrug
Also called rhTNK-tPA
Patients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg before the transfer. A single bolus dose should be administered over 5-10 seconds based on patient weight. Transfer to ECCs for thrombectomy should be initiated immediately after Tenecteplase administration.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Patients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg before the interhospital transfer or the physician departure. A single bolus dose should be administered over 5-10 seconds based on patient weight. Transfer to ECCs or physician travelling for thrombectomy should be initiated immediately after Tenecteplase administration. Receives: Drug: Tenecteplase thrombolysis |
| Control group | No intervention | Patients will receive standard treatment and be directly transferred to ECCs or transfer physician for EVT according to Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dichotomized mRS of 0-2 vs. 3-6
Dichotomized mRS of 0-2 vs. 3-6 at 90±7 days; 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)
Measured: 90±7 days
Secondary outcomes (9)
Ordinal mRS score
Ordinal mRS score at 90 (±7) days; 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)
Measured: 90 (±7) days
Dichotomized mRS of 0-1 vs. 2-6
Dichotomized mRS of 0-1 vs. 2-6 at 90 (±7) days
Measured: 90 (±7) days
Dichotomized mRS of 0-3 vs. 4-6
Dichotomized mRS of 0-3 vs. 4-6 at 90 (±7) days
Measured: 90 (±7) days
Early dramatic clinical response rate
Early dramatic clinical response rate at 24 (±12) h, defined as a NIHSS score of 0 or 2 or NIHSS drop of ≥8 from baseline
Measured: 24 (±12) hours
Arterial recanalization during interhospital transfer
Arterial recanalization during interfacility transfer, evaluated with the angiography (CTA/MRA/first run of DSA) at ECC
Measured: At ECC before thrombectomy or physician-arrival
Successful reperfusion
Successful reperfusion at end-of-procedure angiography, defined as expanded Treatment in Cerebral Infarction (eTICI) score of 2b, 2c, or 3 on angiography
Measured: At end-of-procedure angiography (up to 15 minutes)
First pass excellent reperfusion
First pass reperfusion defined as eTICI 2c or greater after the first thrombectomy pass
Measured: Immediately after the thrombectomy
Arterial recanalization
Arterial recanalization at 24(±12)h, evaluated with CTA/MRA
Measured: 24(±12) hours
EQ-5D-5L
Score on the EQ-5D-5L at 90 (±7) days;(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life).
Measured: 90 (±7) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start20 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junwei Hao, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203625
- Sponsor's protocol ID
- XMEC-2025-003
- Acronym
- OPTION-2
- Status last verified
- Mar 2026
- First submitted
- 16 Sep 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No