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Efficacy and safety of optimized tenecteplase dose in patients with ischemic stroke without large or medium vessel occlusion within 4.5 hours of onset: a prospective, multicenter, open-label, parallel, randomized controlled clinical trial

Efficacy and safety of optimized tenecteplase dose in patients with ischemic stroke without large or medium vessel occlusion within 4.5 hours of onset: a prospective, multicenter, open-label, parallel, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124514
Enrollment
Unknown
Registered
2026-05-13
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemic stroke

Interventions

Experimental group:Low dose (0.225mg/kg) of TNK was given
Standard-care Group:Standard dose of TNK was administered

Sponsors

Ganzhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. Meet the diagnostic criteria of acute ischemic stroke in the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023; 3. Non-large or middle vessel occlusion confirmed by DSA/MRA/CTA; 4. NIHSS score >=4 and < 25 before thrombolysis; 5. FAST-ED score < 4; 6. Informed consent was signed by the person or legal guardian.

Exclusion criteria

Exclusion criteria: 1. It was clear that the offending vessel was large vessel occlusion and needed endovascular treatment; 2. Intracranial hemorrhage or systemic hemorrhage within 3 months; Other contraindications to intravenous thrombolysis; 3. Severe liver/renal dysfunction: ALT > 3 times normal value at admission /INR > 1.2/ hepatic encephalopathy/previous drug-induced liver dysfunction; Glomerular filtration rate =2 before onset; 5. The predicted survival time of end-stage disease (malignant tumor, end-stage renal disease, etc.) was less than 3 months; 6. Pregnant/lactating period; 7. Other neurological diseases affecting the follow-up neurological function assessment; 8. Oarticipating in other interventional clinical studies.

Design outcomes

Primary

MeasureTime frame
proportion of patients with mRS score 0-1 at 90 days (%);The incidence of symptomatic intracranial hemorrhage (SICH) within 48 hours;

Secondary

MeasureTime frame
90-day EQ-5D-5L scale score;90-day mRS score;The proportion of early improvement in neurological function;Proportion (%) of patients with 90-day mRS score of 0-3 points;Proportion (%) of patients with 90-day mRS score of 0-2 points;

Countries

China

Contacts

Public ContactZeng Guoyong

Ganzhou People's Hospital

hsyygy@126.com+86 797 588 9991

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026