Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621121
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 45 H of Onset of Ischemic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 45 H of Onset of Ischemic Stroke a Multicenter Prospective Observational Real-world StudyTRANSIT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANSIT
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 prevalenceThe majority of studies comparing the efficacy and safety of teneplase and alteplase are predominantly randomized controlled trials with limited representation from real-world studiesThe 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 studyThe 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 includedThe enrolled patients received treatment with tenecteplase rhTNK-tPA at a dosage of 025 mgkg up to a maximum of 25 mg or alteplase rtPA at a dosage of 09 mgkg 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 90The primary efficacy endpoint was the proportion of excellent functional outcomes at 907 days modified Rankin Scale score mRS 0 or 1The primary safety outcome was the proportion of sICH within 36 h as defined by The European Cooperative Acute Stroke Study III criteriaThe economic endpoint included the total costs of the first hospitalization and the days at home within 907 days
6000 individuals who met the indications for intravenous thrombolysis and signed informed consent were includedThe enrolled patients received treatment with tenecteplase rhTNK-tPA at a dosage of 025 mgkg up to a maximum of 25 mg or alteplase rtPA at a dosage of 09 mgkg 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 90The primary efficacy endpoint was the proportion of excellent functional outcomes at 907 days modified Rankin Scale score mRS 0 or 1The primary safety outcome was the proportion of sICH within 36 h as defined by The European Cooperative Acute Stroke Study III criteriaThe economic endpoint included the total costs of the first hospitalization and the days at home within 907 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None