Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ

NCT06414499 | Recruiting Phase 3 DMC

• 1 other identifier: NCRC-2024-03
• Study Type: interventional
• Target: 1,386
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg/kg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral limb weakness or speech impairment within 4.5 hours of onset.

Conditions

Minor Ischemic Stroke

Keywords

minor stroke; tenecteplase

Outcome Measures

Primary Outcomes (1)

• Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days).

  Modified Rankin Scale score, mRS 0-1

  at 90-day (± 7 days)

Secondary Outcomes (16)

• Good functional outcome (mRS 0-2) at 90-day (± 7 days)

  at 90-day (± 7 days)

• mRS score at 90-day (± 7 days)

  at 90-day (± 7 days)

• COSMOS Scale 0-1 at 90-day (±7days)

  90-day± 7days

• COSMOS scale at 90-day (±7 days)

  90-day± 7days

• NIHSS 0-1 at 24-hour, 7-day or before discharge (analyze which occurs first) or/ neurological improvement (NIHSS decreased≥4 from baseline)

  at 24-hour, 7-day or before discharge (analyze which occurs first)

Study Arms (2)

Aspirin combined with clopidogrel

PLACEBO COMPARATOR

Aspirin 100mg combined with clopidogrel 300mg, plus placebo intravenous rhTNK-tPA

Drug: Control group (Aspirin combined with clopidogrel)

rhTNK-tPA (0.25 mg/kg)

EXPERIMENTAL

rhTNK-tPA (0.25 mg/kg, max 25 mg) with placebo oral aspirin and clopidogrel

Drug: rhTNK-tPA

Interventions

rhTNK-tPA DRUG

rhTNK-tPA 0.25mg/kg, the maximum dose does not exceed 25mg: 1 vial is dissolved in 3ml of sterile water for injection to prepare a medicinal solution with a concentration of 5.33mg/ml. Calculate the total amount of the drug according to the weight of participant, and the maximum dose shall not exceed 25 mg. It is administered as a single bolus intravenous injection, and the injection is completed within 5-10 seconds. Additionally, placebo oral aspirin and clopidogrel are given. Aspirin 100 mg and clopidogrel 300 mg are administered within 6 ± 2 hours following thrombolytic therapy.

rhTNK-tPA (0.25 mg/kg)

Control group (Aspirin combined with clopidogrel) DRUG

Dual antiplatelets with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel are administered within 6 ± 2 hours following intravenous placebo.

Aspirin combined with clopidogrel

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;
• Onset-to-treatment time \< 4.5 h; onset time defined as "last known well" time;
• Clinical diagnosis of minor ischemic stroke (NIHSS ≤ 5) with persistent unilateral limb weakness or speech symptoms, defined as a score of ≥1 on either the language item or a single limb item of the NIHSS;
• Pre-stroke mRS 0-1;
• Informed consent signed.

You may not qualify if:

• Planned or likely acute endovascular treatments before randomization;
• NIHSS 1a \> 2;
• Known allergic to rhTNK-tPA;
• History of intracranial hemorrhage;
• Severe head trauma or previous stroke within 3 months；
• Intracranial or spinal surgery within 3 months;
• Gastrointestinal or urinary tract hemorrhage within 3 weeks；
• Major surgery within 2 weeks;
• Arterial puncture at a non-compressible site within 1 week；
• Intracranial tumors (excluding neuroectodermal tumors, e.g., meningiomas), large intracranial aneurysms, or arteriovenous malformations；
• Intracranial hemorrhage, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
• Active visceral bleeding;
• Concomitantaortic arch dissection;
• Acute bleeding tendency, including platelet count \<100×10⁹/L or other clinically significant conditions;
• Uncontrolled hypertension after active antihypertensive treatment: systolic blood pressure \>180 mm Hg or diastolic \>100 mm Hg;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

Control Groups; Clopidogrel

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yongjun Wang, MD, PhD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Central Study Contacts

Yongjun Wang, MD, PhD

CONTACT

86-13911172565; yongjunwang@ncrcnd.org.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: professor

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: July 9, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)