Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy

Last updated: August 29, 2024
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

3

Condition

Stroke

Blood Clots

Thrombosis

Treatment

Alteplase

Clinical Study ID

NCT05856851
SYSKY-2023-390-02
  • Ages > 18
  • All Genders

Study Summary

A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial aiming at evaluating the efficacy and safety of intra-arterial recombinant human tissue plasminogen activator (rt-PA) after successful recanalization of acute large vessel occlusion in the anterior circulation by mechanical thrombectomy in improving the 90-day functional outcome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18 years or older.

  2. Clinical diagnosis of acute ischemic stroke.

  3. Time from symptom onset to randomization within 24 hours, including wake-up strokeor no-witness stroke; the onset time refers to "Last Known Well" (LKW).

  4. CTA or MRA confirmed occlusion of the intracranial segment of the internal carotidartery, or M1 or M2 segment of the middle cerebral artery; stable eTICI score of 2b50-3 after mechanical thrombectomy, with or without intravenous thrombolysis.Patients with an eTICI score of 2b50-3 on the diagnostic cerebral angiography beforemechanical thrombectomy are also eligible for the study.

  5. Baseline NIHSS of 6-25.

  6. NCCT/DWI-MRI ASPECTS ≥ 6;

  7. Pre-stroke mRS score ≤ 1, or mRS >1 but not related to neurological disease (e.g.,amputation, blindness).

  8. Signed informed consent.

Exclusion

Exclusion Criteria:

  1. Contraindication to rt-PA (except time to therapy).

  2. Planned use of dual antiplatelet therapy within the first 24 hours after mechanicalthrombectomy.

  3. Angiographic evaluation showing dissection, severe stenosis, or complete occlusionof the carotid artery, which requires the use of carotid artery stents during theendovascular procedure.

  4. Suspected cerebral vasculitis based on medical history and/or angiographicevaluation.

  5. Women who are pregnant or breastfeeding.

  6. Participation in other clinical trials.

  7. Preoperative intracranial hemorrhage confirmed by cranial CT or MRI.

  8. Known genetic or acquired bleeding disposition with anticoagulation factordeficiency.

  9. Coagulation disorder with INR > 1.7 or use of new oral anticoagulants (within 48hours of symptom onset).

  10. Platelet count <50X10^9/L.

  11. Suspected vascular occlusion as a result of infective endocarditis.

  12. Known severe renal insufficiency with glomerular filtration rate <30 ml/min or bloodcreatinine >220 μmol/L (2.5 mg/dl).

  13. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication toiodine contrast.

  14. Suspected aortic dissection.

  15. Previous parenchymal organ surgery or biopsy in the last 1 month;

  16. Any active bleeding or recent bleeding (gastrointestinal, urinary tract bleeding,etc.) in the last 1 month;

  17. SBP > 185 mmHg or DBP > 110 mmHg refractory to treatment.

  18. Anticipated life expectancy < 6 months (e.g., malignancy, severe cardiopulmonarydisease, etc.).

  19. Any condition that, in the judgment of the investigator, makes the patientunsuitable for this study or where this study may impose a significant risk to thepatient (e.g., inability to understand and/or comply with study procedures and/orfollow-up due to psychiatric disorders, cognitive or emotional impairment).

Study Design

Total Participants: 324
Treatment Group(s): 1
Primary Treatment: Alteplase
Phase: 3
Study Start date:
August 01, 2023
Estimated Completion Date:
December 31, 2025

Study Description

This study is a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the efficacy and safety of intra-arterial recombinant human tissue plasminogen activator (rt-PA) after successful recanalization of acute large vessel occlusion in the anterior circulation by mechanical thrombectomy (eTICI 2b50/3). The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-1.

Study intervention: (1) Participants in the experimental group will receive intra-arterial alteplase (a dose of 0.225 mg/kg and a maximum dose of 20 mg) after the mechanical thrombectomy, and will receive standard medical treatment after the procedure. (2) Participants in the control group will receive standard medical treatment without intra-arterial alteplase.

A total of 324 participants are anticipated to be recruited for this study, with 162 participants in each group (1:1 ratio).

Connect with a study center

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, Guangdong
    China

    Active - Recruiting

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