Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

NCT07475949 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2026-K0007
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke; Tenecteplase

Outcome Measures

Primary Outcomes (1)

• Excellent outcome

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

  90 (±14) days

Secondary Outcomes (5)

• Level of disability

  90 (±14) days

• Functional independence

  90 (±14) days

• Early neurological improvement

  24 (±12) hours

• Change in stroke severity

  7 (±1) days or at discharge

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

  90 (±14) days

Other Outcomes (4)

• Symptomatic intracranial hemorrhage

  24 (±12) hours

• Any intracranial hemorrhage

  24 (±12) hours

• Extracranial bleeding

  24 (±12) hours

Study Arms (2)

Control group

OTHER

Standard Medical Treatment

Other: Standard medical treatment

Tenecteplase group

EXPERIMENTAL

Intravenous tenecteplase thrombolysis

Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg); Other: Standard medical treatment

Interventions

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.

Tenecteplase group

Standard medical treatment 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.

Control group; Tenecteplase group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• National Institutes of Health Stroke Scale (NIHSS) score of 6-25 (both inclusive).
• Pre-stroke modified Rankin Scale (mRS) score of 0-1.
• Written informed consent from patients or their legally authorized representatives.

You may not qualify if:

• 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.
• Hypodensity on non-contrast CT \>1/3 middle cerebral artery territory.
• Severe traumatic brain injury or other major trauma in the past 3 months.
• Intracranial neoplasm, arteriovenous malformation, or aneurysm (≥10mm).
• Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months.
• Gastrointestinal or urinary tract hemorrhage in the past 3 weeks.
• Active internal bleeding.
• Aortic dissection.
• Infective endocarditis.
• Platelet count \<100×10\^9/L.
• Women who are pregnant or breastfeeding.
• Blood glucose \<50 or \>400 mg/dL (\<2.78 or \>22.2 mmol/L).

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Yuan Wu, MD, PhD

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Pan, MD, PhD

CONTACT

86-156 2648 3251; dongpan012@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study drug will be open-label, but outcome assessors remain unaware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (1)