Type 2 diabetes and acute cerebral infarction
Conditions
Interventions
Treatment Arm:In addition to standard antiplatelet intravenous thrombolysis and/or endovascular treatment patients in the treatment group received an adjunctive therapy with 1.4-g CZTL capsules 3 time
Control Arm:In addition to standard antiplatelet, intravenous thrombolysis and/or endovascular treatment, patients in the control group received an adjunctive therapy with 1.4-g placebo capsules 3 tim
Sponsors
Beijing Tiantan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Age = 18 years 2) Diagnosed with acute ischemic stroke 3) Within 24 hours from symptom onset 4) Baseline NIHSS score ranging 4 from 25 5) Known pre-existing diabetes or newly diagnosed diabetes (HbA1c = 6.5% at admission)
Exclusion criteria
Exclusion criteria: 1) mRS score > 1 at randomization (premorbid historical assessment) 2) ASPECTS or pc-ASPECTS = 6 confirmed by pretreatment CT scan 3) Diagnosed with intracranial hemorrhagic diseases (including intracranial hemorrhage subarachnoid hemorrhage etc) 4) Already use any drugs containing Leech Chuanxiong Salvia and Astragalus between onset and randomization 5) Appeared with dysphagia before randomization 6) With history of coagulation disorders hemorrhagic diathesis neutropenia or thrombocytopenia 7) With history of liver or kidney dysfunction (= 3× upper limit of normal alanine transaminase or = 2× upper limit of normal creatinine) 8) With history of severe cardiopulmonary diseases judged by investigators 9) Having severe non-cardiovascular comorbidity with life expectancy < 3 months or failed to follow the study for other reasons 10) History of drug or food allergy or known to be allergic to the composition of drugs in this study 11) Contraindications to digital subtraction angiography procedure including severe allergy for contrast agent with or without iodine 12) Pregnancy or lactation or childbearing women with documented negative pregnancy test but without reliable contraception 13) Incapable to follow this study for mental illness and cognitive or emotional disorders 14) Unsuitable for this study in the opinion of the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with a favorable functional outcome at 90 days after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in NIHSS score change from baseline to 14 days (or hospital discharge whichever comes earlier);Cerebral infarction volume at 14 days (or hospital discharge whichever comes earlier);Recurrent symptomatic ischemic stroke within 90 days;The proportion of patients with a favorable functional outcome at 14 days (or hospital discharge whichever comes earlier);Combined vascular events within 90 days;The EuroQol Five Dimensions (EQ-5D) quality-of-life score at 90 days; | — |
Countries
China
Contacts
Public ContactXu Tong
Beijing Tiantan Hospital Capital Medical University
Outcome results
None listed