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NCT Number: NCT07475936

Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke

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.

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Key information

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location contact

Dong Pan, MD, PhD

CONTACT

[email protected]

86-156 2648 3251

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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

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.

Primary outcomes

  1. Excellent outcome

    Time frame: 90 (±14) days

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

Secondary outcomes

  1. Level of disability

    Time frame: 90 (±14) days

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

  2. Functional independence

    Time frame: 90 (±14) days

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

  3. Early neurological improvement

    Time frame: 24 (±12) hours

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

  4. Change in stroke severity

    Time frame: 7 (±1) days or at discharge

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

  5. Quality of life measured by EQ-5D-5L

    Time frame: 90 (±14) days

    EQ-5D-5L scale score at 90 days.

Other outcomes

  1. Symptomatic intracranial hemorrhage

    Time frame: 24 (±12) hours

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

  2. Any intracranial hemorrhage

    Time frame: 24 (±12) hours

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

  3. Extracranial bleeding

    Time frame: 24 (±12) hours

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

  4. Mortality

    Time frame: 90 days

    All cause death within 90 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Pan, MD, PhD

CONTACT

[email protected]

86-156 2648 3251

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Guangxi Medical University

Other

Registry information

Official study title

A Multicenter, Prospective, Observational, Real-World Registry Study of Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

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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