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

Last updated: March 27, 2025
Sponsor: General Hospital of Shenyang Military Region
Overall Status: Completed

Phase

3

Condition

Stroke

Cardiac Ischemia

Cerebral Ischemia

Treatment

Tenecteplase

Clinical Study ID

NCT05657444
Y (2022) 168
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years;

  • Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 ofmiddle 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

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 ofupper limit of normal value), elevated serum creatinine (more than 1.5 times ofupper limit of normal value) or requiring dialysis;

  • Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolicblood 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.

Study Design

Total Participants: 380
Treatment Group(s): 1
Primary Treatment: Tenecteplase
Phase: 3
Study Start date:
March 21, 2023
Estimated Completion Date:
March 20, 2025

Connect with a study center

  • General Hospital of Northern Theater Command

    ShenYang, 110840
    China

    Site Not Available

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