NCT07203625

Brief 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 artery occlusion (BAO) between 4.5-24 hours of symptom onset.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for phase_4

Timeline
19mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

September 16, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

September 16, 2025

Last Update Submit

March 16, 2026

Conditions

Acute Ischemic StrokeBasilar Artery Occlusion

Keywords

basilar artery occlusionthrombolysisinterhospital transfer

Outcome Measures

Primary Outcomes (1)

  • 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)

    90±7 days

Secondary Outcomes (9)

  • Ordinal mRS score

    90 (±7) days

  • Dichotomized mRS of 0-1 vs. 2-6

    90 (±7) days

  • Dichotomized mRS of 0-3 vs. 4-6

    90 (±7) days

  • Early dramatic clinical response rate

    24 (±12) hours

  • Arterial recanalization during interhospital transfer

    At ECC before thrombectomy or physician-arrival

  • +4 more secondary outcomes

Other Outcomes (3)

  • Symptomatic intracranial hemorrhage （sICH）

    36 hours

  • Parenchymal hematoma type 2 (PH2)

    36 hours

  • All cause mortality

    90 (±7) days.

Study Arms (2)

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.

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.

Interventions

Tenecteplase thrombolysisDRUG

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.

Also known as: rhTNK-tPA
Interventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

  • 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 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Junwei Hao, MD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junwei Hao, MD

CONTACT

01083198277haojunwei@vip.163.com

Gaoting Ma, MD

CONTACT

01083198082demo_doctor@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2025

First Posted

October 2, 2025

Study Start

January 20, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)