NCT07168278Not yet recruitingPhase 3
Tenecteplase vs Medical Management in 4.5-24h LVO no Access to EVT
Tenecteplase vs Medical Management in 4.5-24h Anterior Circulation Large Vessel Occlusion With no Access to EVT
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 794 (estimated)
- First submitted
- 5 Sept 2025
- Start date
- 1 Nov 2025
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Diseases
- Stroke
- NCT number
- NCT07168278
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 794
- From 1 Nov 2025 to the primary completion date, 1 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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；
Lab values
- 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)；
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.