Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ(TRACE Ⅳ)

Last updated: August 25, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Stroke

Occlusions

Thrombosis

Treatment

Control group

Single/dual antiplatelet therapy

rhTNK-tPA

Clinical Study ID

NCT06414499
NCRC-2024-03
  • Ages > 18
  • All Genders

Study Summary

The trial is a multicenter, prospective, open-label, blinded-endpoint randomized controlled design. Participants with acute minor ischemic stroke (baseline NIHSS≤5) accompanied with DWI/FLAIR mismatch will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria

  1. Age ≥ 18 years;

  2. Can be treated with study drug within 12 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle);

  3. Clinical diagnosis of minor ischemic stroke (baseline NIHSS≤5) with a measurable neurological deficit defined as impairment of language or motor function;

  4. DWI/FLAIR mismatch on magnetic resonance imaging.

  5. Pre-stroke mRS 0-1;

  6. Informed consent signed.

Exclusion Criteria

  1. Contradictory or unable to complete MRI examination.

  2. Planned or likely acute endovascular treatments (any angioplasty or vascular surgery);

  3. NIHSS 1a > 2;

  4. Known allergic to rhTNK-tPA;

  5. Known history of intracranial hemorrhage;

  6. Clinical stroke or serious head/spinal trauma within 3 months;

  7. Intracranial or spinal surgery within 3 months;

  8. Known history of gastrointestinal or urinary tract hemorrhage in the previous 21 days.

  9. Participants with a history of major surgery in the previous 14 days;

  10. Arterial puncture at a non-compressible site in the previous 7 days.

  11. Participants with intracranial tumors (excluding neuroectoderm origin, such as meningioma), huge intracranial aneurysm, or arterio-venous malformation.

  12. Intracranial hemorrhage (including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma)

  13. Participants with active visceral bleeding;

  14. Participants with aortic arch dissection;

  15. Participants with a known bleeding diathesis or with a platelet count < 100×109/L;

  16. Participants with a systolic blood pressure > 180 or a diastolic blood pressure > 100 mmHg after repeated measurements and aggressive treatments;

  17. Blood glucose < 2.8 or > 22.2 mmol / L);

  18. Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis);

  19. Receive intravenous thrombolysis within 24 hours;

  20. Receive direct oral anticoagulant therapy with international normalized ratio (INR) > 1.7s or PT > 15 s;

  21. Receive low molecular weight heparin or heparinoid within 24 hours;

  22. Receive thrombin inhibitors or factor Xa inhibitors within 48 hours;

  23. Receive GP2b3a inhibitors within 72 hours;

  24. Participants who have large areas (greater than one third of middle cerebral artery territory) of obvious low density on the baseline CT scan;

  25. Participants with a seizure at onset thought to be presenting with postictal paralysis (Todd's paralysis) mimicking stroke.

  26. Participants with severe infection, such as bacterial endocarditis, pericarditis, acute pancreatitis;

  27. Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control;

  28. Participation in another clinical study with an experimental product in the previous 3 months;

  29. Participants deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.

Study Design

Total Participants: 1394
Treatment Group(s): 3
Primary Treatment: Control group
Phase: 3
Study Start date:
August 26, 2024
Estimated Completion Date:
December 31, 2025

Study Description

The study will be a multicenter, prospective, open-label, blinded-endpoint randomized controlled trial (2 arms with 1:1 randomization). Participants with acute minor ischemic stroke (baseline NIHSS≤5) within 12 hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) accompanied with measurable neurological deficit and DWI/FLAIR mismatch will be enrolled. The measurable neurological deficit is defined as impairment of language or motor function. Participants will be randomized into 2 groups: Intervention group (rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg. Control group: Standard medical care according to the guideline. The primary endpoint is excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day.

Connect with a study center

  • Beijing Tiantan Hospital

    Beijing, Beijing
    China

    Active - Recruiting

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