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Recruiting NCT06010628

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

Phase IV Interventional Stroke, Ischemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tenecteplase.
Who it may be relevant to
Registry conditions: Stroke, Ischemic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of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

Interventions

  • Drug Tenecteplase
    intravenous tenecteplase (0.25 mg/kg, a single bolus over 5 to 10 seconds, a maximum of 25 mg).

Primary outcome measures

  • proportion of modified Rankin Scale (mRS) 0-1 [Time frame: 90±7 days]
Secondary outcome measures (11)
  • proportion of modified Rankin Scale (mRS) 0-2 [Time frame: 90±7 days]
  • ordinal distribution of modified Rankin Scale (mRS) [Time frame: 90±7 days]
  • change in National Institute of Health stroke scale (NIHSS) score [Time frame: 24 (-6/+12) hours]
  • change in National Institute of Health stroke scale (NIHSS) score [Time frame: 10±2 days]
  • occurrence of early neurological improvement (ENI) [Time frame: 24 (-6/+12) hours]
  • new stroke or other vascular event(s) [Time frame: 90±7 days]
  • all-cause mortality [Time frame: 90±7 days]
  • symptomatic intracranial hemorrhage (sICH) [Time frame: 24 (-6/+12) hours]
  • intracranial hemorrhage [Time frame: 24 (-6/+12) hours]
  • major systemic bleeding event [Time frame: 24 (-6/+12) hours]
  • any bleeding event [Time frame: 24 (-6/+12) hours]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Hui-Sheng Chen — Shenyang
  • Department of Neurology, General Hospital of Northern Theater Command — Shenyang

Identifiers

NCT: NCT06010628 · Y (2023) 144

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗