Acute medium vessel occlusion stroke
Conditions
Interventions
Control group:After randomization, participants received standard medical therapy recommended by the guidelines, including antiplatelets, anticoagulation, statins, and other conventional therapies.
TNK group:After randomization, participants received intraarterial thrombolysis with rhTNK-tPA and standard medical therapy as recommended by guidelines.
Sponsors
Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) age >=18 years; (2)Imaging-confirmed acute isolated intracranial medium vessel occlusion (M2 segment of middle cerebral artery, with a diameter of =5, Or NIHSS = 2); (6) The subject or legal representative signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) intracranial hemorrhage confirmed by head CT or MRI before randomization; (2) mRS score >=2 before onset; (3) systolic blood pressure> 185mmHg or diastolic blood pressure> 110mmHg, Poor controlled with antihypertensive drugs; (4) received or plan to undergo mechanical thrombectomy; (5) arterial puncture within one week; (6) major surgical surgery or severe trauma in the last 2 weeks; (7) intracranial or spinal canal surgery and substantial organ biopsy in recent 30 days; (8) history of major head trauma or stroke in the last 3 months; (9) inherited or acquired hemorrhagic tendancy; deficiency of anticoagulant factors; or on oral anticoagulant with an INR> 1.7; (10) blood glucose 22.2mmol/L (400 mg/dl), platelets count 200 mmol/L (2. 5 mg/dl); (13) pregnant or lactating women; (14) allergic to rh TNK-tPA or contrast; (15) participating in other clinical trials; (16) any advanced disease with a life expectancy of <6 months; (17) cannot complete follow-up; (18) deemed unsuitable by the investigator to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infarct volume at 72+/-24h; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90d mRS 0-1 ;90d mRS 0-2;90d mRS 0-3;90d mRS distribution;Early neurological deterioration(change in NIHSS=2 from baseline to 72h);NIHSS at 7d or discharge; | — |
Countries
China
Contacts
Public ContactXiang Luo
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed