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Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

ConditionsAcute Ischemic StrokeTenecteplase
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Guangxi Medical University

About this trial

The benefit of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, e.g. wake-up stroke, remains uncertain. This randomized study aims to assess the efficacy and safety of intravenous tenecteplase following non-contrast CT screening for acute ischemic stroke with unknown time of onset.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old.

Clinical diagnosis of acute ischemic stroke.

Unknown time of stroke onset (e.g., stroke symptom recognized on awakening) but last-known normal time >4.5 hours.

Time from stroke symptom recognition (e.g., awakening) to randomization within 3 hours.

Disqualifiers

Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage.

Rapid neurological improvement with NIHSS <6 at randomization.

Allergy to tenecteplase.

Use of vitamin K antagonist with INR >1.7, use of heparin or low molecular heparin in the past 24 hours, or use of direct oral anticoagulants in the past 48 hours.

Trial design

Design model

Parallel

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, administered as soon as possible after the randomization.

  • Standard medical treatment

    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

352 Participants
are divided into 2 treatment groups
Group A: Control groupOther 1 intervention
Group B: Tenecteplase groupExperimental treatment 2 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 (±12) hours.

Time frame
24 (±12) hours
4

Change in stroke severity

The change of NIHSS score from baseline 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 randomization (Heidelberg criteria)

Time frame
24 (±12) hours
2

Any intracranial hemorrhage

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

Time frame
24 (±12) hours
3

Extracranial bleeding

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

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

This trial is not recruiting at the moment. You can still explore other options: