Status:
RECRUITING
Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROB...
Detailed Description
Adult acute ischemic stroke patients due to large vessel occlusion (Middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA) with baseline National Institutes of Health Stroke Scale (NIHSS) 6-2...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old;
- Acute ischemic stroke symptom onset between 24 to 72 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-seen normal time';
- Pre-stroke modified Rankin scale (mRS) score ≤1;
- Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive);
- Neuroimaging:
- Middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA, middle cerebral artery M1 or M2 being responsible for signs and symptoms of acute ischemic stroke;
- target mismatch profile on CTP or MRI+PWI (ischemic core volume \<70mL, mismatch ratio ≥1.8, and mismatch volume ≥15mL);
- Written informed consent from patients or their legally authorized representatives.
Exclusion
- Present as a significant low-density lesion on CT
- Allergy to tenecteplase
- Rapidly improving symptoms at the discretion of the investigator
- NIHSS consciousness score 1a \>2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate
- Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), despite blood pressure-lowering treatment
- Blood glucose \<2.8 or \>22.2 mmol/L (point of care glucose testing is acceptable)
- Active internal bleeding or at high risk of bleeding, e.g., major surgery, trauma or gastrointestinal or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days
- Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR \>1.7 or prothrombin time \>15 seconds; use of any direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours unless reversal of effect can be achieved with a reversal agent; any full dose heparin/heparinoid during the last 24 hours or with an aPTT greater than the upper limit of normal
- Known defect of platelet function or platelet count below 100,000/mm3 (NB patients taking antiplatelet medication can be included)
- Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial hemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm, arteriovenous malformation, or giant aneurysm
- Any terminal illness such that the patient would not be expected to survive more than 1 year
- Unable to perform CTP or PWI
- Hypodensity in \>1/3 MCA territory on non-contrast CT
- Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI
- Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion)
- Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial
- Unlikely to adhere to the trial protocol or follow-up
- 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
- Participation in other interventional clinical trials within the previous 3 months
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT06954155
Start Date
May 30 2025
End Date
May 30 2027
Last Update
November 19 2025
Active Locations (1)
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1
Beijing tiantan hospital
Beijing, China, 100070