Tenecteplase Clot-Busting Drug Compared With Standard Care for Large Stroke
Tests tenecteplase against standard care in adults with a large-vessel blood clot stroke.
Plain-language title generated from the registry record
Registry title: Tenecteplase vs Medical Management in 4.5-24h LVO no Access to EVT
Key facts
- Where
- Hefei, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had an ischemic stroke 4.5 to 24 hours ago, caused by a blocked large brain artery, and who cannot get clot removal (EVT).
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute ischemic stroke 4.5 to 24 hours from last seen well, with a blocked large artery (ICA terminus, M1 or dominant M2) on CTA or MRA. NIHSS 6 to 25, Aspect 7 or more, and a clinical-imaging mismatch.
- Earlier treatment
- No access to EVT at the time of randomization. Not on effective blood thinners, no heparin in the past 48 hours with prothrombin time above the standard limit, and no other interventional trial in the past 3 months.
Main reasons for not taking part
- Past or recent significant bleeding, brain bleeding, or a known bleeding tendency
- Stroke in the past 3 months, or a stroke history together with diabetes
- Blood pressure above 185/110 mmHg or needing intensive treatment to lower it
- Blood glucose below 2.8 or above 22.2 mmol/L, or platelet count below 100×10⁹/L
- Pregnant or nursing women, or life expectancy under 1 year
Read by machine on 9 November 2026.
Where in China
- The First Affiliated Hospital of University of Science and Technology of ChinaHefei, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of University of Science and Technology of China
- Trial code
- NCT07168278
- Record updated
- 11 September 2025
- Original description
The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. The main question it aims to answer is: Does tenectplase improve the 90-days functional outcome in participants with acute large vessel occlusion? Researchers will compare tenectplase thrombolysis to non-use to see if tenectplase works to improve the functional outcome in participants with onset 4.5-9 hours. Participants will:* Receive 0.25mg/kg (max 25mg) tenectplase at admission (after randomization) .* Receive neurological assessment at admission, Day 5-7 or on hospital discharge (whichever earlier). Audio or video of the assessment may be recorded if possible.* Receive brain CT + CT angiogram + CT perfusion and MRI after randomization, where the CT scan may be repetitive.Read full original descriptionShow less
Tenecteplase vs Medical Management in 4.5-24h Anterior Circulation Large Vessel Occlusion With no Access to EVT
The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. The main question it aims to answer is: Does tenectplase improve the 90-days functional outcome in participants with acute large vessel occlusion? Researchers will compare tenectplase thrombolysis to non-use to see if tenectplase works to improve the functional outcome in participants with onset 4.5-9 hours. Participants will:* Receive 0.25mg/kg (max 25mg) tenectplase at admission (after randomization) .* Receive neurological assessment at admission, Day 5-7 or on hospital discharge (whichever earlier). Audio or video of the assessment may be recorded if possible.* Receive brain CT + CT angiogram + CT perfusion and MRI after randomization, where the CT scan may be repetitive.
Inclusion: Age 18 years or greater; Acute ischemic stroke presenting in the 4.5 to 24 hour window from last seen well (including wake-up stroke and no witness stroke); Prestroke mRS 0-2; NIHSS 6 to 25; Aspect ≥ 7; ICA terminus, M1, dominant M2 occlusion on CTA or MRA; Clinical-imaging mismatch assessed by investigator; Patients with no access to EVT at the time of randomization.
Exclusion: Over the past 3 months, undergone major surgery, organ biopsy, or suffered a serious injury; Over the past 2 weeks, receiving prolonged ( >2 minutes) cardiopulmonary resuscitation, childbirth, or non-stressful vascular puncture (such as subclavian or jugular vein puncture); SBP >185 mmHg or DBP >110 mmHg, or requiring intensive treatment (intravenous antihypertensive drugs) to lower blood pressure to within limits; Current or past history of significant bleeding over the past 6 months; History of intracranial hemorrhage (including possible subarachnoid hemorrhage or subarachnoid hemorrhage due to an aneurysm) or evidence or suspected intracranial hemorrhage; Known bleeding tendency; Recent severe or dangerous bleeding, or active ulcerative gastrointestinal disease; History of central nervous system injury (e.g., intracranial tumor, aneurysm, or arteriovenous malformation, intracranial or spinal surgery), or recent head injury；; Tumors that increase risk of bleeding; Severe liver dysfunction, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis; Stroke episode occurred with epileptic seizure; History of stroke comorbid with diabetes; History of stroke over the past 3 months；; Patients receiving effective anticoagulant therapy (vitamin K antagonists with INR > 1.3, or other oral anticoagulants exceeding the upper limit of the corresponding standard range); Acute bleeding tendency, including platelet count below 100×10⁹/L or other conditions; Blood glucose <2.8 mmol/L or >22.2 mmol/L (<50 mg/dL or >400 mg/dL)；; Know arterial / venous malformation or aneurysm; Bacterial endocarditis, pericarditis, or acute pancreatitis; Heparin use within the past 48 hours and prothrombin time exceeding the upper limit of the standard range; Patient life expectancy of less than 1 year; Simultaneous occlusion of multiple blood vessels, defined as bilateral MCAs or MCAs combined with the basilar artery; Pregnant women or nursing mothers；; Patients with a low likelihood of 3-month follow-up；; Over the past 3 months participated in other interventional clinical trials.