NCT06010628 Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
| NCT ID | NCT06010628 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | General Hospital of Shenyang Military Region |
| Condition | Stroke, Ischemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,440 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2029-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,440 participants in total. It began in 2024-02-01 with a primary completion date of 2029-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 year * Acute ischemic stroke confirmed by non-contrast computed tomography and use of CTA for assessment of LVO as determined by local investigators; * The time from last known well to treatment: 4.5 - 6 hours; * NIHSS ≥ 4 at randomization; * First stroke onset or past stroke without obvious neurological deficit (mRS≤1); * Uncertainty over the benefits and risks of thrombolysis by researcher; * Signed informed consent. Exclusion Criteria: * Pre-stroke disability (mRS≥2); * Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion; * Any contraindication to intravenous thrombolysis: Obvious head injury or stroke within 3 months; Subarachnoid or intracranial hemorrhage; History of intracranial hemorrhage; Intracranial tumor, arteriovenous malformation or aneurysm; Intracranial or spinal cord surgery within 3 months; Myocardial infarction within 3 months; Major surgery within 1 month; Gastrointestinal or urinary tract hemorrhage within the previous 30 days; Arterial puncture at a noncompressible site within the previous seven days; Active internal hemorrhage; Coagulation abnormalities: platelet count of \<100000/mm3; Aortic arch dissection; Heparin therapy within 24 hours; Infective endocarditis; Oral warfarin is being taken and INR\>1.6 or APTT abnormal; Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg; Blood glucose \< 50 mg/dl (2.7mmol/L); Neurological deficit after epileptic seizures; * Pregnancy; * Allergy to test drugs; * Comorbidity with other serious diseases; * Participating in other clinical trials within 3 months; * Patients not suitable for the study considered by researcher.
Frequently Asked Questions
Who can join the NCT06010628 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Ischemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06010628 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06010628 currently recruiting?
Yes, NCT06010628 is actively recruiting participants. Visit ClinicalTrials.gov or contact General Hospital of Shenyang Military Region to inquire about joining.
Where is the NCT06010628 trial being conducted?
This trial is being conducted at Shenyang, China, Shenyang, China.
Who is sponsoring the NCT06010628 clinical trial?
NCT06010628 is sponsored by General Hospital of Shenyang Military Region. The trial plans to enroll 1,440 participants.
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