A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke
NCT ID: NCT06621121
Last Updated: 2024-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6000 participants
OBSERVATIONAL
2024-10-26
2026-10-01
Brief Summary
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Detailed Description
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6000 individuals who met the indications for intravenous thrombolysis and signed informed consent were included.The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg, or alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg, based on their clinical condition and the preferences expressed by the patients and their families. Assessments were conducted at baseline, as well as at 24, 36, and 72 hours post-thrombolysis. Follow-up evaluations were performed on day 7 (or prior to discharge) and day 90.The primary efficacy endpoint was the proportion of excellent functional outcomes at 90±7 days (modified Rankin Scale score, mRS 0 or 1).The primary safety outcome was the proportion of sICH within 36 h (as defined by The European Cooperative Acute Stroke Study III criteria).The economic endpoint included the total costs of the first hospitalization and the days at home within 90±7 days.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TNK group
The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg.
Tenecteplase
The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg, based on their clinical condition and the preferences expressed by the patients and their families.
rtPA group
The enrolled patients received treatment with alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg.
Alteplase
The enrolled patients received treatment with alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg, based on their clinical condition and the preferences expressed by the patients and their families.
Interventions
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Tenecteplase
The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg, based on their clinical condition and the preferences expressed by the patients and their families.
Alteplase
The enrolled patients received treatment with alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg, based on their clinical condition and the preferences expressed by the patients and their families.
Eligibility Criteria
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Inclusion Criteria
3\. Age ≥18 years old; 4. Signed informed consent by patients or their legally authorized representative.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Tianjin Huanhu Hospital
OTHER
Responsible Party
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Jialing Wu
MD,PhD
Principal Investigators
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Jialing Wu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Huanhu Hospital
Locations
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Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WJL-2024-10
Identifier Type: -
Identifier Source: org_study_id
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