Intravenous TNK vs TPA for AIS Treatment on MSU,a Prospective Multicenter RCT

Phase 4

Recruiting

• Conditions: Intravenous; Acute Ischemic Stroke; Thrombosis
• Interventions: Drug: tenecteplase

• Registration Number: NCT06498323
• Lead Sponsor: Mahidol University

Brief Summary

Acute ischemic stroke is one of the devastating diseases that increase hospitalization, disabilities, and deaths worldwide. Current treatment with intravenous thrombolytic agent can help reduce disabilities and improve quality of life. Intravenous Alteplase is proven benefit and now used as the first-line drug for acute ischemic stroke with symptom onset less than 4.5 hours and without contraindications.

Tenecteplase, a genetically engineered tissue-type plasminogen activator, has been questioned to treat acute ischemic stroke instead of intravenous alteplase. Tenecteplase has more advantages over alteplase including higher fibrin specificity, longer half-life and easier to administer as a single intravenous bolus. The efficacy and safety of intravenous tenecteplase has been studied recently. In 2017, A phase 3 randomized open-label, blinded trial (NOR-TEST) 6 showed that there were no significant differences in efficacy and safety between tenecteplase and alteplase in mild stroke patients. A study in 2020, in the setting of acute large artery occlusion, Tenecteplase resulted in a better 90-day neurological outcome and provided more benefits in reperfusion before endovascular thrombectomy10. Regarding safety concerns, tenecteplase showed no significant higher incidence of intracerebral hemorrhage. Administration, tenecteplase might be better in the setting of the case on mobile stroke units. Assuming, earlier reperfusion by thrombolytic drug may have improved patient's neurologic outcomes. We aim to compare the efficacy and safety between intravenous tenecteplase and alteplase in acute ischemic stroke patients given on mobile stroke units within 4.5 hours after symptom onset.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-13
• Study Start: 2022-08-03
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Diagnosed as Acute ischemic stroke within 4.5 hr of symptom onset
• Age > 18 years old
• No contraindication for thrombolytic drug
• Informed consent from patients

Exclusion Criteria

• Diagnosed as Acute ischemic stroke with more than 4.5 hours of symptom onset or uncontained onset
• Have contraindication for thrombolytic drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tenecteplase	tenecteplase	Intravenous tenecteplase (0.25mg/kg) will be given in acute ischemic stroke patients on mobile stroke units within 4.5 hours according to the eligibility criteria after randomization allocation.
alteplase	tenecteplase	Intravenous alteplase (0.9mg/kg) will be given in acute ischemic stroke patients on mobile stroke units within 4.5 hours according to the eligibility criteria after randomization allocation.

Primary Outcome Measures

Name	Time	Method
mRS Score	at 3 months	mRS Score

Secondary Outcome Measures

Name	Time	Method
NIHSS Score at 24 hrs	at 24 hours	NIHSS Score at 24 hrs after intravenous tenecteplase

Trial Locations

Locations (1)

Siriraj Stroke Center,Siriraj Hospital; 🇹🇭 Bangkok, Thailand