Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

Phase 3Not Yet RecruitingNCT07475949

First Affiliated Hospital of Guangxi Medical University352 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

352

Conditions

Acute Ischemic Stroke Tenecteplase

Interventions

Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)DRUG

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.

Standard medical treatmentOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. Rapid neurological improvement with NIHSS \<6 at randomization. 3. Allergy to tenecteplase. 4. 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. 5. Hypodensity on non-contrast CT \>1/3 middle cerebral artery territory. 6. Severe traumatic brain injury or other major trauma in the past 3 months. 7. Intracranial neoplasm, arteriovenous malformation, or aneurysm (≥10mm). 8. Intracranial surgery, intraspinal surgery, or other major surgery in the past 3 months. 9. Gastrointestinal or urinary tract hemorrhage in the past 3 weeks. 10. Active internal bleeding. 11. Aortic dissection. 12. Infective endocarditis. 13. Platelet count \<100×10\^9/L. 14. Women who are pregnant or breastfeeding. 15. Blood glucose \<50 or \>400 mg/dL (\<2.78 or \>22.2 mmol/L). 16. Systolic blood presure \>185 mmHg or diastolic blood presure \>110 mmHg refractory to treatment. 17. Life expectancy \<3 months. 18. Participating in other trials. 19. 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).

Locations (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Outcomes

Primary Outcomes

Excellent outcome

The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days

Time frame: 90 (±14) days

Secondary Outcomes

Level of disability

Ordinal shift analysis of the mRS with 5-6 merged at 90 days.

Time frame: 90 (±14) days

Functional independence

The proportion of mRS score of 0-2 at 90 days.

Time frame: 90 (±14) days

Early neurological improvement

The proportion of NIHSS 0-1 or ≥4 points reduction at 24 (±12) hours.

Time frame: 24 (±12) hours

Change in stroke severity

The change of NIHSS score from baseline to 7 days or at discharge (whichever comes first)

Time frame: 7 (±1) days or at discharge

Quality of life measured by EQ-5D-5L

EQ-5D-5L scale score at 90 days.

Time frame: 90 (±14) days

Central Contacts

Dong Pan, MD, PhD

CONTACT

86-156 2648 3251 dongpan012@hotmail.com

Data from ClinicalTrials.gov

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