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Tests treatment safety and results for Stroke, Ischemic
Official title Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke
ClinicalTrials.gov ID: NCT06658197
What this study is testing
What is Tenecteplase?
Tenecteplase is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stroke, ischemic.
Also referred to as TNK.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Arterial occlusion of the internal carotid artery (ICA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), M1 or M2 segment of the...
- Prestroke mRS score ≤2.
- Informed consent from the patient or legally authorised representative.
You likely can't join if
- Patients diagnosed with hemorrhagic stroke (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage...
- 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.
See the full eligibility criteria
- 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...
- Prestroke mRS score ≤2.
- Informed consent from the patient or legally authorised representative.
- 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.
- 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.