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NCT06010628RecruitingPhase 4

Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)

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

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
1440 (estimated)
First submitted
20 Aug 2023
Start date
Feb 2024
Primary completion date
Dec 2029
Lead sponsor
General Hospital of Shenyang Military Region
Diseases
Stroke
NCT number
NCT06010628

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 1440
  • From Feb 2024 to the primary completion date, Dec 2029
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Pre-stroke disability (mRS≥2);
  • Allergy to test drugs;
  • Comorbidity with other serious diseases;

Lab values

  • 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;

Other

  • Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion;
  • Pregnancy;
  • Participating in other clinical trials within 3 months;
  • Patients not suitable for the study considered by researcher.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hui-Sheng Chen
Coordinator of this site? Confirm its status
ShenyangChinaRecruiting
Department of Neurology, General Hospital of Northern Theater Command
Coordinator of this site? Confirm its status
ShenyangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.