Tenecteplase for Late-Window Stroke Guided by DWI-FLAIR Mismatch

NCT07540416 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: MISMATCH-001
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of tenecteplase administered 4.5-9 hours after stroke onset (defined as the time the patient was first found with symptoms, including wake-up stroke and unwitnessed stroke) in patients with acute ischemic stroke (AIS) guided by DWI-FLAIR mismatch on MRI. The main questions it aims to answer are:

• Tenecteplase group: received tenecteplase, intravenously as a bolus administered over a period of 5 to 10 seconds at a dose of 0.25 mg per kilogram (maximum dose, 25 mg), plus aspirin placebo (300 mg).
• Control group: aspirin (300 mg) plus tenecteplase placebo. From day 2 to day 90, all patients will be conformed to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.

Conditions

Acute Ischemic Stroke

Keywords

Tenecteplase; Thrombolysis; diffusion weighted imaging; fluid attenuated inversion recovery

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS)

  Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 ± 7 days.

  90 ± 7 days

Secondary Outcomes (6)

• Modified Rankin Scale (mRS)

  90 ± 7 days

• Modified Rankin Scale (mRS)

  90 ± 7 days

• National Institutes of Health Stroke Scale (NIHSS)

  24 hours and 7 days

• Barthel (BI)

  90 ± 7 days

• EuroQol 5-Dimension (EQ-5D)

  90 ± 7 days

Other Outcomes (4)

• Symptomatic intracranial hemorrhage (sICH)

  36 hours

• Death

  90 days

• Systemic bleeding

  90 days

Study Arms (2)

Tenecteplase group:

EXPERIMENTAL

Patients will receive tenecteplase, intravenously as a bolus administered over a period of 5 to 10 seconds at a dose of 0.25 mg per kilogram (maximum dose, 25 mg), plus aspirin placebo (300 mg) immediately after randomization.From day 2 to day 90, all patients will be conformed to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.

Drug: TNK-tPA; Drug: Placebo

Control group

ACTIVE COMPARATOR

Patients will receive asprin(300mg) plus intravenous TNK(placebo, 0.25mg/kg, a maximum of 25 mg) immediately after randomization. From day 2 to day 90, patients will be conformed to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.

Drug: Aspirin; Drug: Placebo

Interventions

TNK-tPA DRUG

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

Tenecteplase group:

Aspirin DRUG

Asprin (300mg)

Control group

Placebo DRUG

Asprin (placebo)

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;
• AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);
• Imaging criteria:
• DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;
• DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;
• NIHSS score 4-25;
• First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1);
• Signed informed consent from the patient or legally authorized representative.

You may not qualify if:

• Planned endovascular treatment;
• Contradictory to MRI examination;
• MRI image not qualified for evaluation;
• Serious neurological deficits before onset (mRS≥2);
• Obvious head injuries or strokes within 3 months;
• Subarachnoid or intracranial hemorrhage;
• History of intracranial hemorrhage;
• Intracranial tumor, arteriovenous malformation or aneurysm;
• Intracranial or spinal cord surgery within 3 months;
• Active internal hemorrhage;
• platelet count of \<100000/mm3;
• Aortic arch dissection;
• Heparin therapy within 24 hours;
• Oral warfarin is being taken and INR\>1.6 or APTT abnormal;
• Oral anticoagulation therapy;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

TNK-tissue plasminogen activator; Aspirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Bo Song, MD

  Department of Neurology, the First Affiliated Hospital of Zhengzhou University

  STUDY CHAIR

Central Study Contacts

Bo Song, MD

CONTACT

+86-371-66278068; fccsongb@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician、Professor

Model Details: TNK group: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) and asprin (placebo) Control group: Asprin (300mg) plus TNK (placebo)

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1)