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RECRUITING
NCT06414499
PHASE3

Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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.

Official title: TNK-tPA Treatment for Acute Minor Ischemic Stroke:A Randomized, Double-blind, Double-dummy Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1386

Start Date

2025-07-09

Completion Date

2026-10-31

Last Updated

2025-07-24

Healthy Volunteers

No

Interventions

DRUG

rhTNK-tPA

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.

DRUG

Control group (Aspirin combined with clopidogrel)

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.

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China