NCT07469293
Not yet recruiting
Phase 3
Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial
Southwest Hospital, China43 sites in 1 country488 target enrollmentStarted: February 15, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Southwest Hospital, China
- Enrollment
- 488
- Locations
- 43
- Primary Endpoint
- Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years old
- •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;
- •NlHSS score ≥ 5
- •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)
- •Patients with premorbid mRS 0 or 1
- •Written informed consent obtained from the participant or a legally authorized representative
Exclusion Criteria
- •Intracranial hemorrhage confirmed by cranial CT or MRI;
- •Already received intravenous thrombolysis;
- •Planned mechanical thrombectomy;
- •Intraoperative DSA showing vessel rupture, dissection, or contrast agent extravasation;
- •Pregnant or breastfeeding women;
- •Allergy to contrast agents or tenecteplase;
- •Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and failure to control with oral antihypertensive medications;
- •Genetic or acquired bleeding disorders, coagulation factor deficiencies; coagulation dysfunction, INR \> 1.7, or use of novel oral anticoagulants within 48 hours;
- •Blood glucose \< 2.8 mmol/L (50 mg/dL) or \> 22.2 mmol/L (400 mg/dL), platelet count \< 100 × 10\^9/L;
- •History of bleeding within the past month (gastrointestinal or urinary tract bleeding);
Arms & Interventions
TNK intra-arterial thrombolysis group
Experimental
Intra-arterial thrombolysis
Intervention: Intra-arterial thrombolysis (Procedure)
Standard medical therapy group
Active Comparator
Only standard medical therapy
Intervention: Standard medical treatment (Other)
Outcomes
Primary Outcomes
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1
Time Frame: 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 Outcomes
- Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH)(up to 48 hours)
- Improvement in NIHSS between baseline and 5-7 days(at 5-7 days from randomization)
- Distribution of Modified Rankin Scale (mRS)(At Day 90±7 days)
- Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2(At Day 90±7 days)
- EQ-5D-5L score(At Day 90±7 days)
- All-cause mortality(up to 90 days)
Investigators
Zhenhua Zhou
Professor
Southwest Hospital, China
Study Sites (43)
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