Stroke
Conditions
Interventions
Intervention group:Intravenous injection cyclosporine A before standard therapy
Placebo Control Group:Intravenous injection normal saline before standard therapy
Sponsors
Shanghai Ninth Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
15 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-85 years; 2. Clinical signs and symptoms consistent with the diagnosis of acute large artery occlusion of anterior circulation; 3. Onset time within 6 to 24h (Including wake-up stroke or ambiguous time since stroke onset. Onset time is defined as patients with the symptoms of acute is-chemic stroke. If the onset time is not clear, it could be estimated as last time patient was seen normal); 4. Baseline NIHSS =10; 5. mRS score equals to or lower than 1; 6. Imaging Inclusion Criteria: exclude intracranial hemorrhage as evidenced by CT; brain parenchymal low density changes or the disappeared brain drain are-as lower than 1/3 blood supply of intracranial internal carotid artery (ICA); Occlusion of the intracranial ICA, middle cerebral artery (MCA)-M1 and/or preponderant MCA-M2 as evidenced by MRA or CTA; 7. Subjects or subject's legally authorized representatives have signed the study in-formed consent form.
Exclusion criteria
Exclusion criteria: 1. Women who were pregnant or in lactation period; 2. Rapid neurological improvement or with the evidence of revascularization be-fore randomization; 3. Existing psychiatry or nervous system defect which would be hard to analyze the patient's condition objectively; 4. Known allergy to CsA, castor oil, polyoxymethylene, contrast agent, nickel or titanium; 5. Baseline blood glucose22.0mmol/L; 6. Uncontrollable stubborn high pressure (SBP=185mmHg or DBP=110 mmHg); 7. Severe renal dysfunction: creatinine=133 µmol/l or patients self-report the needing hemodialysis or peritoneal dialysis; 8. Known liver disease (prothrombin time3 or Baseline platelet count 1/3 MCA low-density lesions (or>100ml low-density lesions in all) evi-denced by CT; 5. ASPECTS<6 evidenced by non-contrast CT; 6. Posterior circulation infarct evidenced by CT/MRI; 7. Poor collateral circulation evidenced by CTA (score 0 or 1); 8. Vascular occlusions in multiple parts (e.g., bilateral anterior circulation, or ante-rior circulation / vertebrobasilar system) hinted by CTA/MRA, or bilateral strokes or multiple parts strokes with clinical evidence; 9. Not suitable for thrombectomy hinted by CTA: including extremely circuity vessels hard to reach the focus, poor collateral circulation with large infarct lesion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cerebral infarct volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Rankin Score (mRS);Change of National Institutes of Health Stroke Scale (NIHSS) score after treatment comparing with baseline;European five-dimensional health scale (EQ-5D) score;Favorable outcome;Incidence of hemorrhagic transformation (hematoma type);Patient health questionnaire - 9 (PHQ-9) score;New incidence of ischemic stroke;Serious adverse event;volume of new low density range; | — |
Countries
China
Contacts
Public ContactJian-Ren Liu,Jieqing Wan
Shanghai Ninth Hospital, Shanghai Jiao Tong University School of Medicine; Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed