A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTianjin Huanhu Hospital
About this trial
Stroke is the second leading cause of death worldwide, killing nearly 7 million people every year. Acute ischemic stroke is caused by focal cerebral hypoperfusion, usually due to embolism or atherosclerotic disease . Ischemic strokes account for 60-70% of all strokes worldwide and are severely debilitating, drawing considerable attention due to their high prevalence.The majority of studies comparing the efficacy and safety of teneplase and alteplase are predominantly randomized controlled trials with limited representation from real-world studies.The aim of this study is to compare the safety, efficacy and economic benefits of recombinant human TNK tissue plasminogen activator (tenecteplase, rhTNK-tPA, TNK) and recombinant tissue plasminogen activator (alteplase, rtPA) in clinical practice. This study aimed to establish a foundation for refining intravenous thrombolytic therapy tailored to various patient profiles and to guide clinicians in selecting the most suitable thrombolytic treatment options.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
1. Any absolute contraindication to thrombolysis in the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023" 2.Allergy to TNK or alteplase 3.Participation in another clinical trial within the previous 3 months. 4.Other conditions deemed inappropriate for participation in this study.
Trial population
Patients with acute ischemic stroke within 4.5 hours last known well (including wake-up stroke and no witness stroke )were included in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tenecteplase
Other interventionThe 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
Other interventionThe 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.
Treatment groups
6,000 Participants
are divided into 2 treatment groupsGroup A: TNK group1 intervention
Group B: rtPA group1 intervention
Trial outcomes
Primary outcomes
1
mRS
The primary efficacy endpoint is the proportion of excellent functional outcome at 90±7 days (modified Rankin Scale score, mRS 0 or 1).The modified Rankin Scale is commonly used to measure neurological recovery after stroke on a scale of 0-6, with higher scores associated with worse outcomes .
Time frame
90±7 days after enrollmentSecondary outcomes
1
NIHSS score
Incidence of neurological improvement at 72h after treatment (proportion of subjects with NIHSS score ≤1 point or 8 points or more lower than baseline )
Time frame
72h after treatment2
proportion of sICH
The safety outcome is the proportion of sICH within 36 hours (as defined by The European Cooperative Acute Stroke Study III criteria）
Time frame
36h after treatment3
rate of death
Secondary safety end points related to Rate of death from any cause within and Rate of systemic bleeding within 90 days.
Time frame
90 days after enrollment4
mRS
Improvement of mRS Scores at 90±7 days (shift analysis)
Time frame
90±7 days after enrollmentSponsors and contacts
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Source ClinicalTrials.gov