Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ

Phase 3

Recruiting

• Conditions: Minor Ischemic Stroke
• Interventions: Drug: Control group (Aspirin combined with clopidogrel); Drug: rhTNK-tPA

• Registration Number: NCT06414499
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

This study is a multicenter, prospective, randomized, double-blind, double-dummy controlled (2 arms with 1:1 randomization) trial. Participants with acute minor ischemic stroke (baseline NIHSS≤5) within 4.5 hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) will be enrolled. Eligible patients must have neurological deficits involving at least language or motor function. Participants will be randomized into 2 groups: Intervention group (rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg, plus placebo oral aspirin and clopidogrel. Aspirin 100mg and clopidogrel 300mg will be given within 6 ± 2 hours after thrombolytic therapy. Control group: Dual antiplatelet therapy with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel will be given within 6 ± 2 hours following the placebo thrombolytic therapy.The primary endpoint is an excellent functional outcome (a modified Rankin Scale score of 0-1) at 90-day.

Study Timeline

• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-16
• Status Verified: 2025-07
• Study Start: 2025-07-09
• Last Update Submitted: 2025-07-20
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-07-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1386

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin combined with clopidogrel	Control group (Aspirin combined with clopidogrel)	Aspirin 100mg combined with clopidogrel 300mg, plus placebo intravenous rhTNK-tPA
rhTNK-tPA (0.25 mg/kg)	rhTNK-tPA	rhTNK-tPA (0.25 mg/kg, max 25 mg) with placebo oral aspirin and clopidogrel

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	shift analysis/ordinal distribution of mRS score 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	shift analysis/ordinal distribution of COSMOS scale at 90-day (±7 days)
Total mortality within 90-day (± 7 days)	within 90-day (± 7 days)
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)
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 7 days or before discharge.	within 7 days or before discharge
Neurological deterioration at 90 days	90-day (±7 days)	defined as an increase of ≥4 points in NIHSS score compared to baseline.
New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ myocardial infarction/vascular death) at 90-day (± 7 days), with each vascular event being independently evaluated.	at 90-day (± 7 days)
Adverse events/Severe adverse events within 90-day (± 7 days)	within 90-day (± 7 days)
European quality of life visual analogue scale at 90 days	at 90-day (± 7 days)
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 36-hour.	within 36-hour
Any intracranial hemorrhage within 90-day (± 7 days)	within 90-day (± 7 days)
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 90-day (± 7 days)	within 90-day (± 7 days)
PH2 type intracranial hemorrhage according to the Heidelberg criteria within 90-day (± 7 days)	within 90-day (± 7 days)
Severe bleeding events according to the GUSTO criteria within 90-day (± 7 days)	within 90-day (± 7 days)

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China