Status:
COMPLETED
Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Ischemic Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The trial is a multicentre, prospective, open-label, blinded endpoint (PROBE), phase 3, randomized controlled design. Patients with acute ischemic stroke due to basilar artery occlusion presenting wit...
Detailed Description
The study will be a multicentre, prospective, open-label, blinded endpoint (PROBE), randomized controlled trial (2 arm with 1:1 randomization) in patients with acute ischemic stroke due to basilar art...
Eligibility Criteria
Inclusion
- Age ≥18.
- 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.
- 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.
- Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
- Local legal requirements for consent have been satisfied.
Exclusion
- Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
- 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).
- Significant cerebellar mass effect or acute hydrocephalus.
- Established frank hypodensity on non-contrast CT indicating subacute infarction.
- Bilateral extensive brainstem ischemia.
- Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability).
- Other standard contraindications to intravenous thrombolysis.
- Contraindication to imaging with contrast agents.
- Clinically evident pregnant women.
- Vessel imaging showing both anterior and posterior circulation large vessel occlusion.
- Current participation in another research drug treatment protocol.
- Known terminal illness such that the patients would not be expected to survive a year.
- Planned withdrawal of care or comfort care measures.
- 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.
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2025
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT06196320
Start Date
January 24 2024
End Date
September 22 2025
Last Update
November 26 2025
Active Locations (59)
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1
Taihe County Traditional Chinese Medicine Hospital
Fuyang, Anhui, China
2
Lixin County People's Hospital
Haozhou, Anhui, China
3
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
4
First People's Hospital of Tianshui
Tianshui, Gansu, China