Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users

NCT07092709 | Recruiting Phase 3 DMC

• 1 other identifier: SYSKY-2025-484-01
• Study Type: interventional
• Target: 912
• Locations: 1 country
• Sites: 1

Brief Summary

An investigator-initiated, multicenter, randomized, placebo-controlled, double-blind trial to determine the efficacy and safety of intravenous tenecteplase thrombolysis in acute ischemic stroke (AIS) patients with recent direct oral anticoagulants (DOACs) intake in improving the 90-day functional outcome.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The modified Rankin Scale score (mRS) 0-1

  The proportion of mRS score 0-1 at 90 (±14) days.

  90 (±14) days

Secondary Outcomes (6)

• The modified Rankin Scale score (mRS) 0-2

  90 (±14) days

• The modified Rankin Scale score (mRS) 0-3

  90 (±14) days

• Level of disability

  90 (±14) days

• The proportion of NIHSS 0-1 or ≥4 points reduction

  24 (±12) hours

• Quality of life (EQ-5D-5L)

  90 (±14) days

Other Outcomes (4)

• SAFETY OUTCOME: Symptomatic intracranial hemorrhage

  24 (±12) hours

• SAFETY OUTCOME: Any intracranial hemorrhage

  24 (±12) hours

• SAFETY OUTCOME: Major extracranial bleeding

  24 (±12) hours

Study Arms (2)

Intravenous tenecteplase

EXPERIMENTAL

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

Matched placebo

PLACEBO COMPARATOR

Drug: Placebo

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, and within 24 hours of stroke onset.

Intravenous tenecteplase

Placebo DRUG

Matched placebo 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, and within 24 hours of stroke onset.

Matched placebo

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 or older.
• Clinically diagnosed with acute ischemic stroke.
• DOACs intake within 48 hours prior to enrollment, or on an ongoing DOACs therapy but the exact time of last intake is unknown.
• DOACs intake within 24 hours prior to enrollment.
• Study intervention (IVT or placebo) can be started
• within 4.5 hours of last known well (LKW). OR
• within 4.5 to 24 hours of LKW (including wake-up stroke) AND evidence of target mismatch profile on CT perfusion or MR perfusion (ischemic core volume \< 50mL, hypoperfused volume to ischemic core volume ratio \> 1.6, mismatch volume ≥10ml).
• Hypoperfused tissue is defined as Tmax \>6s on CT perfusion or MR perfusion. Ischemic core is defined as rCBF \<30% on CT perfusion or ADC\<620μm\^2/s on diffusion MRI.
• Baseline National Institutes of Health Stroke Scale (NIHSS) 4-25. OR Disabling stroke with baseline NIHSS of 0-3, including complete hemianopia, aphasia, measurable deficit on motor power, or other disabling neurological deficit judged by the investigator.
• Written informed consent signed by patients or their legally authorized representatives.

You may not qualify if:

• Intracranial or subarachnoid hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI), or any intracranial hemorrhage history.
• Allergic to tenecteplase.
• Pre-stroke mRS≥2
• Planned endovascular treatment.
• Currently on dual antiplatelet therapy in addition to DOAC therapy.
• Planned DOAC reversal treatment (including Idarucizumab, Andexanet and tranexamic acid).
• Hypodensity on non-contrast CT estimates to be ≥ 1/3 MCA territory.
• Severe head trauma or other severe trauma in the last 3 months.
• Intracranial tumor, arteriovenous malformation and large-size aneurysm (≥10 mm) found before enrollment.
• Intracranial surgery, intraspinal surgery or other major surgeries within 3 months before enrollment (based on the assessment of the investigators)
• Gastrointestinal or urinary system hemorrhage within the past 3 weeks.
• Active visceral bleeding.
• Aortic arch dissection confirmed by examination or medical history.
• Infective endocarditis confirmed by examination or medical history.
• Platelet count less than 100 × 10\^9 /L.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

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

• Yamei Tang

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Raul G. Nogueira

  UPMC Stroke Institute, Departments of Neurology and Neurosurgery, University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanting Chen

CONTACT

86-20-81332619; chenyt367@mail.sysu.edu.cn

Xinguang Yang

CONTACT

yangxinguang0926@163.com

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: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after the trial completion.
• Access Criteria: The IPD will be available from Principal Investigators (Prof. Yamei Tang and Prof. Raul G. Nogueira) upon reasonable request.

Locations

CN (1)