Acute Ischemic Stroke, Tenecteplase
Conditions
Brief summary
The benefit of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, e.g. wake-up stroke, remains uncertain. This randomized study aims to assess the efficacy and safety of intravenous tenecteplase following non-contrast CT screening for acute ischemic stroke with unknown time of onset.
Detailed description
UTOPIA is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded endpoint (PROBE) trial that aims to assess the efficacy and safety of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, selected by non-contrast CT. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days. Participants randomized to the intervention group will receive intravenous tenecteplase at 0.25 mg/kg with a maximum dose of 25 mg and standard medical treatment, and those randomized to the control group will receive standard medical treatment only, without intravenous thrombolysis.
Interventions
Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg, administered as soon as possible after the randomization.
OTHERStandard medical treatment
Standard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators.
Sponsors
First Affiliated Hospital of Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study drug will be open-label, but outcome assessors remain unaware of group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old. 2. Clinical diagnosis of acute ischemic stroke. 3. Unknown time of stroke onset (e.g., stroke symptom recognized on awakening) but last-known normal time \>4.5 hours. 4. Time from stroke symptom recognition (e.g., awakening) to randomization within 3 hours. 5. National Institutes of Health Stroke Scale (NIHSS) score of 6-25 (both inclusive). 6. Pre-stroke modified Rankin Scale (mRS) score of 0-1. 7. Written informed consent from patients or their legally authorized representatives.
Exclusion criteria
1. Intracranial hemorrhage confirmed by skull CT, or history of intracranial hemorrhage. 2. Planned endovascular treatment. 3. Rapid neurological improvement with NIHSS \<6 at randomization. 4. Allergy to tenecteplase. 5. Use of vitamin K antagonist with INR \>1.7, use of heparin or low molecular heparin in the past 24 hours, or use of direct oral anticoagulants in the past 48 hours. 6. Hypodensity on non-contrast CT \>1/3 middle cerebral artery territory. 7. Severe traumatic brain injury or other major trauma in the past 3 months. 8. Intracranial neoplasm, arteriovenous malformation, or aneurysm (≥10mm). 9. Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months. 10. Gastrointestinal or urinary tract hemorrhage in the past 3 weeks. 11. Active internal bleeding. 12. Aortic dissection. 13. Infective endocarditis. 14. Platelet count \<100×10\^9/L. 15. Women who are pregnant or breastfeeding. 16. Blood glucose \<50 or \>400 mg/dL (\<2.78 or \>22.2 mmol/L). 17. Systolic blood presure \>185 mmHg or diastolic blood presure \>110 mmHg refractory to treatment. 18. Life expectancy \<3 months. 19. Participating in other trials. 20. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excellent outcome | 90 (±14) days | The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of disability | 90 (±14) days | Ordinal shift analysis of the mRS with 5-6 merged at 90 days. |
| Functional independence | 90 (±14) days | The proportion of mRS score of 0-2 at 90 days. |
| Early neurological improvement | 24 (±12) hours | The proportion of NIHSS 0-1 or ≥4 points reduction at 24 (±12) hours. |
| Change in stroke severity | 7 (±1) days or at discharge | The change of NIHSS score from baseline to 7 days or at discharge (whichever comes first) |
| Quality of life measured by EQ-5D-5L | 90 (±14) days | EQ-5D-5L scale score at 90 days. |
Countries
China
Contacts
CONTACTDong Pan, MD, PhD
PRINCIPAL_INVESTIGATORYuan Wu, MD, PhD
First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed