Lschemic stroke
Conditions
Interventions
Standard treatment plus argatroban group:Standard treatment plus argatroban
Sponsors
Second Affiliated Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age >=18 years; 2) Within 24 hours of stroke onset; 3) Anterior circulation intracranial large vessel occlusive stroke confirmed by CTA/MRA/DSA; 4) NIHSS score >= 6 points; 5) ASPECTS score >= 6 points; 6) Received endovascular therapy; 7) Patients or their family members provided written informed consent.
Exclusion criteria
Exclusion criteria: 1) Suspected or confirmed intracranial hemorrhage by head CT or MRI; 2) Pre-stroke mRS score >= 2; 3) mTICI was below grade 2b after vascular recanalization; 4) Allergy to argatroban or contrast agent; 5) Previous stroke in the past 90 days; 6) Previous intracranial aneurysm, arteriovenous malformation, or mass lesions; 7) Clinical presentation suggested a subarachnoid hemorrhage, even if initial CT scan was normal; 8) Surgery or biopsy of parenchymal organ in the past 30 days; 9) Trauma with internal injuries or ulcerative wounds in the past 30 days; 10) Severe trauma in the past 90 days; 11) Systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg after aggressive treatment; 12) Blood glucose 22.2mmol/L; 13) Serious systemic hemorrhage in the past 30 days; 14) Genetic or acquired bleeding tendency, deficiency of coagulation factors; or use of anticoagulants with INR>1.7; 15) Pregnant or lactating women; 16) Platelets 220µmol/L; 21) Received Low Molecular Weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin) in full dose within the previous 24 hours; 22) Abnormal PTT within 48 hours prior to randomization after receiving heparin or a direct thrombin inhibitor (such as bivalirudin, argatroban, dabigatran or lepirudin); 23) Received Factor Xa inhibitors (such as Fondaparinaux, apixaban or rivaroxaban) within the past 48 hours; 24) Other serious, advanced, or terminal illness or any other condition that the investigator felt would pose a significant hazard to the patient if argatroban therapy was initiated; 25) Currently participating in other clinical trial; 26) Any disease that leads to an expected lifespan of less than 6 months; 27) Unable to complete follow-up as expected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of 90-day mRS Score;Incidence of symptomatic intracranial hemorrhage;90-day mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of 90-day mRS Scores 0-1;The proportion of 90-day mRS Scores 0-2;The proportion of 90-day mRS Scores 0-3;Changes of NIHSS score 5-7 days after surgery;90-day EQ-5D scale score;Incidence of any intracranial hemorrhage within 48 hours;Systemic bleeding; | — |
Countries
China
Contacts
Public ContactWenjie Zi
Second Affiliated Hospital of Army Medical University, PLA
Outcome results
None listed