NCT06010628
Recruiting
Phase 4
Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2): a Prospective, Randomized, Open Label, Blinded Endpoint, and Multi-center Study
General Hospital of Shenyang Military Region2 sites in 1 country1,440 target enrollmentFebruary 1, 2024
Overview
- Phase
- Phase 4
- Intervention
- Tenecteplase
- Conditions
- Stroke, Ischemic
- Sponsor
- General Hospital of Shenyang Military Region
- Enrollment
- 1440
- Locations
- 2
- Primary Endpoint
- proportion of modified Rankin Scale (mRS) 0-1
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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.
Investigators
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region
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.
Arms & Interventions
Control group
standard stroke care based on national guideline
Intervention: Tenecteplase
Tenecteplase group
intravenous thrombolysis with tenecteplase
Intervention: Tenecteplase
Outcomes
Primary Outcomes
proportion of modified Rankin Scale (mRS) 0-1
Time Frame: 90±7 days
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Secondary Outcomes
- all-cause mortality(90±7 days)
- intracranial hemorrhage(24 (-6/+12) hours)
- any bleeding event(24 (-6/+12) hours)
- ordinal distribution of modified Rankin Scale (mRS)(90±7 days)
- change in National Institute of Health stroke scale (NIHSS) score(10±2 days)
- occurrence of early neurological improvement (ENI)(24 (-6/+12) hours)
- major systemic bleeding event(24 (-6/+12) hours)
- proportion of modified Rankin Scale (mRS) 0-2(90±7 days)
- symptomatic intracranial hemorrhage (sICH)(24 (-6/+12) hours)
- new stroke or other vascular event(s)(90±7 days)
Study Sites (2)
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