Actively Recruiting
Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke: A Phase 3 Multicenter Open-label Randomized Controlled Trial
Led by Xuanwu Hospital, Beijing · Updated on 2026-04-09
850
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two clot-dissolving drugs for treating acute large vessel occlusion stroke when given within 4.5 hours from symptom onset. This phase III, multicenter, randomized clinical trial compares intravenous tenecteplase followed by mechanical thrombectomy to intravenous alteplase followed by mechanical thrombectomy. The purpose is to assess and compare the effectiveness and safety of these two thrombolytic agents in improving stroke outcomes. Participants will be randomly assigned to one of two treatment groups. One group receives a single rapid intravenous bolus of tenecteplase (0.25 mg/kg, max 25 mg) before the mechanical thrombectomy procedure. The other group receives intravenous alteplase (0.9 mg/kg, max 90 mg) given as a 10% bolus followed by a 90% infusion over one hour before the thrombectomy. Both treatments are followed by the mechanical clot removal procedure. During the study, participants will be followed for 90 days after randomization. Researchers will evaluate functional independence using the modified Rankin Score and other measures such as blood flow restoration on imaging, neurological status, and daily living activities. Safety and treatment effectiveness will be monitored through clinical assessments and imaging at various time points. The total participation time includes initial treatment and follow-up evaluations up to 90 days.
CONDITIONS
Brief Title
Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age is 18 years or older.
- Stroke symptoms started within 4.5 hours, based on last known well time.
- Confirmed artery blockage in internal carotid, anterior cerebral, posterior cerebral, middle cerebral (M1 or M2), or basilar artery on CTA or MRA.
- Prestroke modified Rankin Score of 2 or less.
- Informed consent obtained from patient or legally authorized representative.
You will not qualify if you...
- Hemorrhagic stroke or related conditions on CT scan.
- Contraindication to contrast imaging.
- Coma symptoms (NIHSS score item 1a = 3).
- History of intracranial hemorrhage.
- Severe head trauma or stroke within past 3 months.
- Intracranial or intraspinal surgery within past 3 months.
- Major surgery within past 2 weeks.
- Gastrointestinal or urinary tract bleeding within past 3 weeks.
- Intracranial tumor, arteriovenous malformation, or giant intracranial aneurysm.
- Active visceral bleeding.
- Aortic arch dissection.
- Arterial puncture at non-compressible site within past week.
- Uncontrolled high blood pressure despite treatment (systolic >180 mmHg or diastolic >100 mmHg).
- Acute bleeding tendency including low platelets (<100 x 10^9/L).
- Heparin treatment within past 24 hours.
- Oral anticoagulants with INR >1.7 or PT >15 seconds.
- Use of direct thrombin or Factor Xa inhibitors within past 48 hours.
- Blood glucose below 2.8 mmol/L or above 22.2 mmol/L.
- Large hypodense brain area affecting more than one-third of relevant artery territory on CT.
- Rapidly improving symptoms.
- Participation in another study within past 30 days.
- Terminal illness with life expectancy under 1 year.
- Any condition posing risk or affecting study participation as judged by investigator.
- Pregnant women.
- Known allergy to alteplase, tenecteplase, or excipients.
AI-Screening
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Your Study Journey
Duration - Up to 4.5 hours from stroke symptom onset
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and imaging
Duration - Single treatment session within 4.5 hours of symptom onset
Participants receive intravenous thrombolysis with either tenecteplase or alteplase followed by mechanical thrombectomy to treat acute large vessel occlusion stroke.
1 treatment visit (in-person)
Duration - 90 days from baseline
Participants are followed for safety and functional outcomes after treatment.
Visits at 1, 3, 7, and 90 days post-treatment
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
L
Lu Wang, MD
X
Xiuhai Guo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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