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Completed

NCT Number: NCT05657444

Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)

A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO).

The study aimed to determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

General Hospital of Northern Theater Command

Shenyang, 110840, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years;
  • Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 of middle cerebral artery, basilar artery, or intracranial segment of vertebral artery) who meets criteria for endovascular treatment within 24 hours of stroke onset;
  • The modified Rankin Scale (mRS) score before onset ≤ 2;
  • ASPECTS 6 or greater on CT
  • Signed informed consent.

Exclusion criteria

  • hemorrhagic stroke;
  • Tandem occlusion;
  • Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<100000/mm3);
  • Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), elevated serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
  • Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
  • Patients with contraindication or allergic to any ingredient of drugs in our study;
  • Pregnancy, or plan to get pregnant or during active lactation;
  • Suspected septic embolus or infective endocarditis
  • The estimated life expectancy is less than 6 months due to other serious diseases;
  • Other conditions unsuitable for this clinical study as assessed by researcher.

Treatment and study plan

Tenecteplase

Drug

intra-arterial tenecteplase during endovascular treatment

Primary outcomes

  1. proportion of favorable outcome

    Time frame: Day 90

    Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2

Secondary outcomes

  1. proportion of excellent outcome

    Time frame: Day 90

    Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1

  2. proportion of successful reperfusion after the first-pass or final pass of endovascular treatment

    Time frame: immediately after the first-pass or final pass of endovascular treatment

    Successful reperfusion is defined as defined as modified Thrombolysis In Cerebral Infarction (mTICI) 2b-3

  3. Distribution of modified Rankin Scale (mRS)

    Time frame: Day 90

    mRS scores range from 0 to 6:0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.

  4. Change in cerebral circulation time after intervention

    Time frame: immediately after endovascular treatment

  5. occurrence rate of early neurological improvement

    Time frame: 24 (-6/+24) hours

    early neurological improvement was defined as a 4 point or greater decrease in NIHSS

  6. change in National Institute of Health stroke scale (NIHSS)

    Time frame: 24 (-6/+24) hours

    NIHSS scores range 0-42, with higher scores indicating greater stroke severity

  7. occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events

    Time frame: Day 90

  8. occurrence rate of symptomatic intracranial hemorrhage

    Time frame: 24 (-6/+24) hours

    symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of ≥4 points as a result of the intracranial hemorrhage.

  9. occurrence rate of parenchymal hemorrhage

    Time frame: 24 (-6/+24) hours

    parenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect

  10. percentage of severe adverse events

    Time frame: 24 (-6/+24) hours

  11. cerebral edema

    Time frame: 24 (-6/+24) hours

    cerebral edema was measured as the amount of midline shift of the brain on neuroimaging

  12. death due to all causes

    Time frame: Day 7 or during hospitalization

  13. occurrence rate of the distal emboli after first pass

    Time frame: immediately after first pass

    The emboli means occlusion of the distal artery determined by DSA.

  14. occurrence rate of extracranial hemorrhage

    Time frame: 24 (-6/+24) hours

    extracranial hemorrhage means other bleeding events except intracranial hemorrhage

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Collaborators

  • Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning

Registry information

Official study title

Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II): a Prospective, Randomized, Adaptive Enrichment, Open-label, Blinded End Point, Multi-center Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2022
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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