Stroke, IschemicPhase 3TNK-LVONCT06658197
Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke
A Phase 3 study testing Tenecteplase and Alteplase in people with Stroke, Ischemic and Stroke, Acute, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
A phase III, multicentre, prospective, randomised, open-label, blinded-endpoint clinical trial will evaluate two thrombolytic agents for the treatment of acute large vessel occlusion stroke within 4.5 hours from symptoms onset: intravenous tenecteplase bridging mechanical thrombectomy vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke, Acute, Thrombosis, Brain
- What is being tested?
- Tenecteplase and Alteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to 1 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 is ≥18 years.
- AIS symptom onset ≤4.5 hours, onset time refers to the time the patient was last known to be well. (Recommendation time from thrombolysis to puncture within 60 minutes).
- Arterial occlusion of the internal carotid artery (ICA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery on computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
- Prestroke mRS score ≤2.
- Informed consent from the patient or legally authorised representative.
Who cannot join
- Patients diagnosed with hemorrhagic stroke (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.) or other related conditions identified by CT.
- Contraindication to imaging examinations involving contrast agent injection.
- Patients presenting with clinical symptoms of coma (NIHSS Score Item 1a = 3).
- History of intracranial hemorrhage.
- History of severe head trauma or stroke within the past 3 months.
- Intracranial or intraspinal surgery within the past 3 months.
Show all 25Show fewer
- Major surgery within the past 2 weeks.
- Gastrointestinal or urinary tract bleeding within the past 3 weeks.
- Intracranial tumor, arteriovenous malformation, or giant intracranial aneurysm.
- Active visceral bleeding.
- Aortic arch dissection.
- Arterial puncture at a non-compressible site within the past week.
- Uncontrolled hypertension despite active antihypertensive treatment: Systolic Blood Pressure > 180 mmHg or Diastolic Blood Pressure > 100 mmHg.
- Acute hemorrhagic tendency, including platelet count < 100 × 10⁹/L or other conditions.
- Heparin treatment received within the past 24 hours.
- For patients on oral anticoagulants: INR > 1.7 or PT > 15 seconds.
- Use of direct thrombin inhibitors or direct Factor Xa inhibitors within the past 48 hours.
- Blood glucose < 2.8 mmol/L or > 22.2 mmol/L.
- Hypodensity affecting > 1/3 of the middle cerebral artery territory or an equivalent proportion of the basilar artery territory on non-contrast CT.
- Rapidly improving symptoms as determined by the investigator.
- Participation as a subject in another research study within the past 30 days.
- Any terminal illness where life expectancy is considered not to exceed 1 year.
- Any condition where, in the judgment of the investigator, the study treatment might pose a risk to the patient or affect the patient's participation in the study.
- Pregnant women.
- Known allergy to the active ingredients (Alteplase, Tenecteplase) or any excipients.
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, Beijing Municipality, 100053
Xiuhai Guo, MD, PhD, 86-10-83198852, guoxhxuan@126.com
About this study
Official title: Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) :a Phase 3, Multicentre, Open-label, Randomised Controlled Trial
A phase III, multicentre, prospective, randomised, open-label, blinded-endpoint clinical trial will evaluate two thrombolytic agents for the treatment of acute large vessel occlusion stroke within 4.5 hours from symptoms onset: intravenous tenecteplase bridging mechanical thrombectomy vs. intravenous alteplase bridging mechanical thrombectomy.
Read the detailed description
Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) is a phase III, multicenter, prospective, randomized, open-label, blinded-endpoint clinical trial. Randomization will be 1:1 according to reperfusion treatment modalities: (A) Intravenous thrombolysis with tenecteplase (0.25 mg/kg) plus mechanical thrombectomy vs. (B) Intravenous thrombolysis with alteplase (0.9 mg/kg) plus mechanical thrombectomy. For the primary outcome, the subjects will be followed up within 90 days after randomization. The primary outcome will be the Functional independence defined as modified Rankin Score ≤ 2.
- Conditions
- Stroke, Ischemic, Stroke, Acute, Thrombosis, Brain, Drug Effect
- Being tested
- Tenecteplase, Alteplase
- Keywords
- Ischemic stroke, Tenecteplase
- Medical subject headings
- Ischemic Stroke, Stroke, Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenecteplaseDrug
Also called TNK
Tenecteplase 0.25mg/kg administered as a single rapid intravenous bolus (maximum dose 25mg) plus mechanical thrombectomy
AlteplaseDrug
Also called recombinant tissue plasminogen activator (rtPA)
Alteplase 0.9 mg/kg administered as 10% bolus +90% infusion/1 hour (maximum dose 90mg) plus mechanical thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| tenecteplase | Experimental | Subjects assigned to this arm will receive an intravenous bolus of 0.25mg/kg tenecteplase before the mechanical thrombectomy. Receives: Drug: Tenecteplase |
| alteplase | Active comparator | Subjects assigned to this arm will receive an intravenous 0.9 mg/kg alteplase(10% bolus +90% infusion/1 hour) before the mechanical thrombectomy. Receives: Drug: Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS ≤ 2 at 90 days or no change from baseline
mRS ≤ 2 at 90 days or no change from baseline
Measured: 90 days from baseline
Secondary outcomes (6)
mTICI 2b/3 or absence of retrievable thrombus at initial angiogram
mTICI 2b/3 or absence of retrievable thrombus at initial angiogram
Measured: initial angiogram
mRS at 90 days from baseline
mRS at 90 days from baseline
Measured: 90 days from baseline
mRS 0-1 at 90 days or no change from baseline
mRS 0-1 at 90 days or no change from baseline
Measured: 90 days from baseline
Barthel index at 90 days from baseline
Barthel index at 90 days from baseline
Measured: 90 days from baseline
NIHSS reduce ≥ 8 or reaching 0-1 at 3 days from baseline
NIHSS reduce ≥ 8 or reaching 0-1 at 3 days from baseline
Measured: 3 days from baseline
Change of NIHSS at 1、3、7 days from baseline
Change of NIHSS at 1、3、7 days from baseline
Measured: 1、3、7 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start25 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiuhai Guo, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658197
- Sponsor's protocol ID
- [2024]288-001
- Acronym
- TNK-LVO
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) :a Phase 3, Multicentre, Open-label, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06658197
- Acronym / sponsor ID
- TNK-LVO / [2024]288-001
- Conditions
- Stroke, Ischemic, Stroke, Acute, Thrombosis, Brain, Drug Effect
- Keywords
- Ischemic stroke, Tenecteplase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase III, multicentre, prospective, randomised, open-label, blinded-endpoint clinical trial will evaluate two thrombolytic agents for the treatment of acute large vessel occlusion stroke within 4.5 hours from symptoms onset: intravenous tenecteplase bridging mechanical thrombectomy vs. intravenous alteplase bridging mechanical thrombectomy.
Detailed description
Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) is a phase III, multicenter, prospective, randomized, open-label, blinded-endpoint clinical trial. Randomization will be 1:1 according to reperfusion treatment modalities: (A) Intravenous thrombolysis with tenecteplase (0.25 mg/kg) plus mechanical thrombectomy vs. (B) Intravenous thrombolysis with alteplase (0.9 mg/kg) plus mechanical thrombectomy. For the primary outcome, the subjects will be followed up within 90 days after randomization. The primary outcome will be the Functional independence defined as modified Rankin Score ≤ 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tenecteplase | Experimental | Drug: TenecteplaseSubjects assigned to this arm will receive an intravenous bolus of 0.25mg/kg tenecteplase before the mechanical thrombectomy. |
| alteplase | Active comparator | Drug: AlteplaseSubjects assigned to this arm will receive an intravenous 0.9 mg/kg alteplase(10% bolus +90% infusion/1 hour) before the mechanical thrombectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age is ≥18 years.
- AIS symptom onset ≤4.5 hours, onset time refers to the time the patient was last known to be well. (Recommendation time from thrombolysis to puncture within 60 minutes).
- Arterial occlusion of the internal carotid artery (ICA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery on computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
- Prestroke mRS score ≤2.
- Informed consent from the patient or legally authorised representative.
Key exclusion criteria (25 listed)
- Patients diagnosed with hemorrhagic stroke (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.) or other related conditions identified by CT.
- Contraindication to imaging examinations involving contrast agent injection.
- Patients presenting with clinical symptoms of coma (NIHSS Score Item 1a = 3).
- History of intracranial hemorrhage.
- History of severe head trauma or stroke within the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenecteplaseAlso: TNKTenecteplase 0.25mg/kg administered as a single rapid intravenous bolus (maximum dose 25mg) plus mechanical thrombectomy | Drug | tenecteplase |
| AlteplaseAlso: recombinant tissue plasminogen activator (rtPA)Alteplase 0.9 mg/kg administered as 10% bolus +90% infusion/1 hour (maximum dose 90mg) plus mechanical thrombectomy | Drug | alteplase |
Primary outcome
mRS ≤ 2 at 90 days or no change from baseline
Time frame: 90 days from baseline
mRS ≤ 2 at 90 days or no change from baseline
6 secondary outcomes
mTICI 2b/3 or absence of retrievable thrombus at initial angiogram
Time frame: initial angiogram
mRS at 90 days from baseline
Time frame: 90 days from baseline
mRS 0-1 at 90 days or no change from baseline
Time frame: 90 days from baseline
Barthel index at 90 days from baseline
Time frame: 90 days from baseline
NIHSS reduce ≥ 8 or reaching 0-1 at 3 days from baseline
Time frame: 3 days from baseline
Change of NIHSS at 1、3、7 days from baseline
Time frame: 1、3、7 days from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke, Ischemic
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiuhai Guo, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenecteplase and Alteplase in people with Stroke, Ischemic and Stroke, Acute, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Wang, MD (13161090533, wanglu3261999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS ≤ 2 at 90 days or no change from baseline (time frame: 90 days from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.