Tenecteplase in ReperfUsion Therapy for Posterior Circulation Stroke With Extended Time Window: the TRUST Trial

NCT07073469 | Not Yet Recruiting Phase 3

• 1 other identifier: TRUST
• Study Type: interventional
• Target: 330
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary hypothesis being tested in this trial is that ischemic stroke patients in posterior circulation at 4.5 - 24 hours post onset of stroke will have improved clinical outcomes when given intravenous TNK compared to standard care.

Conditions

Stroke Ischemic

Outcome Measures

Primary Outcomes (1)

• Ordinal distribution of modified Rankin Scale (mRS) score at 90 ± 7 days

  mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome

  90 ± 7 days

Secondary Outcomes (8)

• Excellent recovery assessed by the ratio of modified Rankin Scale (mRS) score of 0-1 (%) at 90 ± 7 days

  90 ± 7 days

• Independent recovery assessed by ratio of modified Rankin Scale (mRS) score of 0-2 (%) at 90 ± 7 days

  90 ± 7 days

• Major neurologic improvement (%) at 24 hours defined as an improvement on National Institutes of Health Stroke Scale (NIHSS) score ≥ 8 points compared with the initial deficit or a score ≤ 1

  24 hours

• Major neurologic improvement (%) at 7 days defined as an improvement on National Institutes of Health Stroke Scale (NIHSS) score ≥ 8 points compared with the initial deficit or a score ≤ 1

  7 days

• Symptomatic intracerebral hemorrhage (sICH) within 36 hours after randomization

  within 36 hours

Study Arms (2)

Experimental: Tenecteplase with standard therapy

EXPERIMENTAL

Patients will receive standard dose intravenous tenecteplase (0.25 mg per kilogram, with a maximum dose of 25 mg)

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

Standard therapy

ACTIVE COMPARATOR

Standard therapy

Other: Standard medical treatment

Interventions

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

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

Experimental: Tenecteplase with standard therapy

Standard medical treatment OTHER

Standard medical treatment according to local guidelines

Standard therapy

Eligibility Criteria

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

You may qualify if:

• Patients presenting with clinical signs of acute ischemic stroke between 4.5 and 24 hours from stroke onset, or wake-up stroke and unwitnessed stroke (if the midpoint of the last known well time is within 4.5 to 24 hours)
• Patients aged \> 18 years (or as per local requirements)
• NIHSS ≥ 4
• Posterior circulation stroke confirmation criteria: If MRI is performed, infarction confirmed by DWI is sufficient. If CT is performed, the non-contrast CT scan must not refute posterior circulation stroke, and clinical signs and symptoms must support the diagnosis, as confirmed by experienced clinicians. If clinical symptoms are atypical, CTA showing symptomatic stenosis or occlusion of large posterior circulation vessels, or CT perfusion showing symptomatic hypoperfusion, can provide additional evidence, though advanced imaging is not mandatory
• Pre-stroke mRS score \< 2
• Informed consent has been obtained from the patient, a family member, or a legally responsible person, depending on local ethics requirements

You may not qualify if:

• Contraindications for tenecteplase:
• Allergy to tenecteplase
• Rapidly improving symptoms at the discretion of the investigator
• The presence of epileptic seizures, hemiplegia after seizures (Todd's palsy), or other neurological/mental illnesses that prevent cooperation or willingness to participate
• Persistent blood pressure elevation (systolic ≥180 mmHg or diastolic ≥100 mmHg) despite treatment
• Blood glucose levels outside the acceptable range (\<2.8 mmol/L or \>22.2 mmol/L), with point-of-care glucose testing considered valid
• High risk of bleeding due to active internal bleeding, major surgery, trauma, gastrointestinal, or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days
• Known impairments in coagulation due to comorbid disease or anticoagulant use, including an INR \>1.7 or prothrombin time \>15 seconds for those on warfarin, recent use of direct thrombin inhibitors or direct factor Xa inhibitors without reversal capability, or full-dose heparin/heparinoid within the last 24 hours with an aPTT above normal limits
• Known defect in platelet function or a platelet count below 100,000/mm³
• History of ischemic stroke, myocardial infarction, intracranial hemorrhage, severe traumatic brain injury, or intraspinal operation within the previous 3 months, or known intracranial neoplasm, arteriovenous malformation, or giant aneurysm
• Acute or past intracerebral hemorrhage identified by CT or MRI
• Infarction of the anterior circulation confirmed by MRI, or vascular examination indicating occlusion of large anterior circulation vessels, or perfusion imaging showing hypoperfusion changes in the anterior circulation area
• Pregnancy, nursing, or unwillingness to use effective contraceptive measures during the trial period
• Likelihood of non-adherence to the trial protocol or follow-up
• Any condition that, in the judgment of the investigator, could impose hazards if study therapy is initiated or affect patient participation in the study

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

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

Central Study Contacts

Min Lou

CONTACT

8615925622176; lm99@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-07