Clinical trial NCT06621121: A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke
Official title: Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke : a Multicenter, Prospective, Observational, Real-world Study（TRANSIT）
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke Acute
Tenecteplase
Alteplase
Keywords: ischemic stroke
tenecteplase
alteplase
Lead sponsor: Tianjin Huanhu Hospital
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: TRANSIT is a prospective, multicenter, open-label real world study.The purpose of this study was 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 practical clinical applications. To provide the basis for optimizing the intravenous thrombolysis program for different types of patients, and to provide a reference for clinicians to choose the appropriate thrombolytic therapy program.

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.

Eligibility criteria: Inclusion Criteria:

- 1. Symptoms of neurological deficit caused by ischemic stroke; 2. The time from onset to treatment ≤4.5 hours; The time of onset of symptoms was defined as the time of last seen normal.

3. Age ≥18 years old; 4. Signed informed consent by patients or their legally authorized representative.

Exclusion Criteria:

* 1. Any absolute contraindication to thrombolysis in the \&#34;Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023\&#34; 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.

Primary outcomes:
measure: mRS
timeFrame: 90±7 days after enrollment
Secondary outcomes:
measure: NIHSS score
timeFrame: 72h after treatment
measure: proportion of sICH
timeFrame: 36h after treatment
measure: rate of death
timeFrame: 90 days after enrollment
measure: mRS
timeFrame: 90±7 days after enrollment
measure: mRS
timeFrame: 90±7 days after enrollment
measure: NIHSS score
timeFrame: 7±1 days after enrollment
measure: stroke recurrence
timeFrame: 90±7 days after enrollment
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Huanhu Hospital
name: Jialing Wu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: