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Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke

ConditionsAcute Ischemic StrokeTenecteplase
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age80+
SponsorFirst Affiliated Hospital of Guangxi Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 80 years;

Clinically diagnosed with acute ischemic stroke and arrived at the hospital within 4.5 hours of symptom onset;

Informed consent signed by the patient or legally authorized representative.

Disqualifiers

Any contraindication to intravenous thrombolysis (excluding age);

Previous treatment with other thrombolytic agents such as alteplase, urokinase, plasminogen activator, or reteplase;

Current participation in other interventional studies;

The investigator deems the patient unsuitable for this study or the study might pose significant risk to the patient (e.g., due to psychiatric disorders, cognitive or emotional impairments that prevent understanding or adherence to study procedures and/or follow-up).

Trial population

This study will consecutively screen patients with acute ischemic stroke (AIS) who are over 80 years of age and arrive at the hospital within 4.5 hours of symptom onset.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)

    Drug

    Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg.

  • Standard medical care

    Other intervention

    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.

Treatment groups

392 Participants
are divided into 2 treatment groups
Group A: Control group1 intervention
Group B: Tenecteplase group2 interventions

Trial outcomes

Primary outcomes

1

Excellent outcome

The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days

Time frame
90 (±14) days

Secondary outcomes

1

Level of disability

Ordinal shift analysis of the mRS with 5-6 merged at 90 days.

Time frame
90 (±14) days
2

Functional independence

The proportion of mRS score of 0-2 at 90 days.

Time frame
90 (±14) days
3

Early neurological improvement

The proportion of NIHSS 0-1 or ≥4 points reduction at 24 hours.

Time frame
24 (±12) hours
4

Change in stroke severity

The change of NIHSS score from enrollment to 7 days or at discharge (whichever comes first).

Time frame
7 (±1) days or at discharge

Other outcomes

1

Symptomatic intracranial hemorrhage

Incidence of symptomatic intracranial hemorrhage within 36 hours from enrollment (Heidelberg criteria).

Time frame
24 (±12) hours
2

Any intracranial hemorrhage

Incidence of any intracranial hemorrhage within 36 hours from enrollment (Heidelberg classification).

Time frame
24 (±12) hours
3

Extracranial bleeding

Incidence of moderate-to-severe extracranial bleeding (GUSTO criteria) within 36 hours from enrollment.

Time frame
24 (±12) hours
4

Mortality

All cause death within 90 days.

Time frame
90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Guangxi Medical University

Lead sponsor

Source ClinicalTrials.gov
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