The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
NCT Number: NCT07475936
The benefit of intravenous tenecteplase in very old patients with acute ischemic stroke (AIS) remain uncertain. This real-world study aims to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset.
Trial opening soon.
Get Notified80 year and older
All sexes
Observational
Nanning, Guangxi, 530021, China
The study is an investigator-initiated, multicenter, prospective, observational, real-world registry designed to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days. The study is anticipated to enroll at least 392 participants, with no less than 196 participants in the tenecteplase group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg.
Standard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators.
Time frame: 90 (±14) days
The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days
Time frame: 90 (±14) days
Ordinal shift analysis of the mRS with 5-6 merged at 90 days.
Time frame: 90 (±14) days
The proportion of mRS score of 0-2 at 90 days.
Time frame: 24 (±12) hours
The proportion of NIHSS 0-1 or ≥4 points reduction at 24 hours.
Time frame: 7 (±1) days or at discharge
The change of NIHSS score from enrollment to 7 days or at discharge (whichever comes first).
Time frame: 90 (±14) days
EQ-5D-5L scale score at 90 days.
Time frame: 24 (±12) hours
Incidence of symptomatic intracranial hemorrhage within 36 hours from enrollment (Heidelberg criteria).
Time frame: 24 (±12) hours
Incidence of any intracranial hemorrhage within 36 hours from enrollment (Heidelberg classification).
Time frame: 24 (±12) hours
Incidence of moderate-to-severe extracranial bleeding (GUSTO criteria) within 36 hours from enrollment.
Time frame: 90 days
All cause death within 90 days.
Contact information is provided by the study sponsor or research team.
First Affiliated Hospital of Guangxi Medical University
Other
A Multicenter, Prospective, Observational, Real-World Registry Study of Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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