Acute Ischemic Stroke
Conditions
Brief summary
DATE-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of tenecteplase combined with standard medications in acute ischemic stroke patients with medium vessel occlusion stroke within 24 hours of onset.
Interventions
PROCEDUREIntra-arterial thrombolysis
A standardized microcatheter-based technique was used to administer recombinant TNK-tPA directly into the thrombus. The total dose (0.0625 mg/kg, max 6.25 mg) was delivered in three equal parts: distally, within the mid-clot, and proximally. Angiographic reassessment at 5 minutes determined if a second identical dose was required (max cumulative dose: 0.125 mg/kg). The procedure was continuously monitored and could be terminated immediately for safety concerns.
OTHERStandard medical treatment
Standard medical treatment
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old 2. Acute isolated intracranial medium vessel occlusion (Distal middle cerebral artery M2; M3 and M4 segments of the middle cerebral artery; A1-A4 segments of the anterior cerebral artery; P1-P3 segments of the posterior cerebral artery), confirmed by imaging, with symptom onset to randomization within 24 hours; 3. NlHSS score ≥ 5 4. CT scan performed within 24 hours confirming that the ischemic lesion does not involve more than one-third of the territory supplied by the responsible vessel (no evidence of early large infarction) 5. Patients with premorbid mRS 0 or 1 6. Written informed consent obtained from the participant or a legally authorized representative
Exclusion criteria
1. Intracranial hemorrhage confirmed by cranial CT or MRI; 2. Already received intravenous thrombolysis; 3. Planned mechanical thrombectomy; 4. Intraoperative DSA showing vessel rupture, dissection, or contrast agent extravasation; 5. Pregnant or breastfeeding women; 6. Allergy to contrast agents or tenecteplase; 7. Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and failure to control with oral antihypertensive medications; 8. Genetic or acquired bleeding disorders, coagulation factor deficiencies; coagulation dysfunction, INR \> 1.7, or use of novel oral anticoagulants within 48 hours; 9. Blood glucose \< 2.8 mmol/L (50 mg/dL) or \> 22.2 mmol/L (400 mg/dL), platelet count \< 100 × 10\^9/L; 10. History of bleeding within the past month (gastrointestinal or urinary tract bleeding); 11. Chronic hemodialysis or severe renal insufficiency (glomerular filtration rate \< 30 mL/min or serum creatinine \> 220 μmol/L (2.5 mg/dL)); 12. Severe mental disorders or inability to provide informed consent and comply with follow-up due to dementia; 13. Concurrent malignant tumors or severe systemic diseases with an expected survival time of less than 90 days; 14. Intracranial aneurysms or arteriovenous malformations; 15. Participation in another clinical interventional trial within 30 days prior to randomization or currently participating in another clinical interventional trial; 16. Occlusions in multiple vascular territories confirmed by CTA/MRA; 17. Other reasons that the investigator deems inappropriate for participation in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1 | At Day 90±7 days | Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) | up to 48 hours | sICH via criteria adapted from the European Cooperative Acute Stroke Study (ECASS III), defined as any apparent extravascular blood in the brain or within the cranium that is associated with clinical deterioration defined by an NIHSS score increase of four points or more from baseline. |
| Improvement in NIHSS between baseline and 5-7 days | at 5-7 days from randomization | National Institutes of Health Stroke Scale (NIHSS) is a 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 6 grades with 0 as normal, and there is an allowance for untestable items.Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits |
| Distribution of Modified Rankin Scale (mRS) | At Day 90±7 days | Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). |
| Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2 | At Day 90±7 days | Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). |
| EQ-5D-5L score | At Day 90±7 days | Health-related quality of life (the score on the EuroQol Group 5-Dimension 5-Level \[EQ-5D-5L\] questionnaire, range,-0.39 to 1, with higher scores indicating better quality of life) |
| All-cause mortality | up to 90 days | All-cause mortality at 90 days |
Countries
China
Contacts
CONTACTXianhua Hou
CONTACTLin Chen
Outcome results
None listed