Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occl… (NCT06559436) | Clinical Trial Compass
RecruitingNot Applicable
Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke
China560 participantsStarted 2024-10-02
Plain-language summary
To assess the safety and efficacy of beyond time window TNK intravenous thrombolysis for distal Medium Vessel Occlusion (MeVO) related stroke in a prospective randomized clinical trial.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Evidence of a primary (e.g., not secondary to endovascular therapy of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the co/non-dominant M2 segment\*, M3, or M4 segment of the middle cerebral artery (MCA), the anterior cerebral artery (ACA) (A1, A2, A3, or A4 segments), or the posterior cerebral artery (PCA) (P1, P2, P3, or P4 segments);
✓. Age ≥18 years;
✓. Premorbid mRS 0-1;
✓. Evidence of a disabling stroke defined as follows:
✓. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥4 at the time of randomization.
✓. NIHSS 2-3 with disabling deficit including significant aphasia, neglect, hemianopsia, or hemiparesis/ loss of hand or leg function as established by the treating team in context of the patient's life.
✓. Less than 50% core in the territory supplied by the occluded vessel as evident by hypodensity and loss of grey-white border on NCCT or ADC \<620 mm2/s on diffusion MRI or rCBF\<30% on CTP after 6h of symptom onset.
✓. Time from onset (or time last seen well) to treatment within 4.5-24 hours;
Exclusion criteria
✕. Received intravenous thrombolysis prior to randomization;
✕. Allergy to Tenecteplase;
✕. Seizures, or other neurological/mental illness at stroke onset if it precludes obtaining an accurate baseline NIHSS;
What they're measuring
1
Rates of 90 day good functional outcomes
Timeframe: 90 (± 14 days) after procedure
Trial details
NCT IDNCT06559436
SponsorThe First Affiliated Hospital of University of Science and Technology of China
✕. Patients planned to undergo MT or other endovascular treatments (e.g., intra-arterial thrombolysis);
✕. Systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg, which cannot be controlled by antihypertensive drug(s);
✕. Acute intracerebral hemorrhage identified by CT or MRI;
✕. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal;
✕. Subjects with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation);