A Randomized,Parallel-controlled Study Of Dual Antiplatelet Therapy And Aspirin Monotherapy In The Treatment Of Mild To Moderate Acute Non-cardiogenic Ischemic Stroke

Objective:With the improvement of modern people's life,people's lifestyle is gradually changing,the incidence of cerebrovascular disease,morbidity,mortality has gradually increased,cerebrovascular disease on human life and health threats are increasing,has become the second leading cause of human death now.At the same time,ischemic stroke is an important part of cerebrovascular disease,ischemic stroke one of the major diseases that harmful to the health of the elderly and the life.In China,cerebral infarction disability is the first place in all diseases,the third mortality rate after ischemic heart disease and cancer.Ischemic stroke,ischemic heart disease and cancer are the three killers of human health.At present,thrombolysis and antiplatelet therapy is an effective means for acute ischemic stroke.Thrombolytic therapy is aimed at ultra-early patients,through the opening of blood vessels to improve neurological function.And antiplatelet therapy mainly to prevent stroke progression and recurrence.Due to the time window,only a small proportion of patients(1.7%in China,10-20%in Europe and the United States)can receive thrombolytic therapy,and most patients require antiplatelet therapy to prevent stroke progression.In recent years,many studies have shown that dual antiplatelet therapy may be more effective than aspirin monotherapy,but also safe.In particular,the Clopidogrel with Aspirin in Acute Minor Stroke or Transient Ischemic Attack(CHANCE)study in 2013 showed that the combination of clopidogrel and aspirin is superior to aspirin alone for reducing the risk of stroke and does not increase the risk of hemorrhage among patients with high-risk transient ischemic attack(TIA)(ABCD2 ? 4)or minor stroke(NIHSS ? 3)who can be treated within 24 hours after the onset of symptoms.However,in clinical practice,in addition to minor stroke(NIHSS<3)and high-risk transient ischemic attack(TIA)(ABCD2>4),mild to moderate acute ischemic stroke(4<NIHSS<10)will lead to disability and death,and thus is still a huge patient population that needing early intervention.Clinically,within 48 hours after onset of acute ischemic stroke is in an unstable period,prone to progress and increase,about 50%of the progress of the population increase occurred in this time window.However,according to the guidelines,aspirin monotherapy is still recommended for this group of patients.There have been some previous studies,such as FASTER,have suggested that aspirin plus clopidogrel dual antiplatelet therapy may be superior to aspirin monotherapy in this population.However,the lack of international large-scale clinical trials to evaluate that the efficacy and safety of dual antiplatelet therapy and aspirin monotherapy in this population at present.Therefore,this study intends 48 hours of onset after mild to moderate acute non-cardiogenic ischemic stroke patients to carry out randomized,parallel controlled study.To observe the efficacy and safety between dual antiplatelet therapy(aspirin plus clopidogrel)and aspirin monotherapy in preventing stroke progression and recurrence events.Materials and Methods:All the 130 mild to moderate acute non-cardiogenic ischemic stroke patients were collected from nuerological department of the first affiliated hosipital of Dalian Medical University from 2015 January to 2017 January.All patients were within 48 hours of onset after mild to moderate acute non-cardiogenic ischemic stroke patients,and 4<NIHSS<10,are consistent with mild to moderate acute ischemic stroke diagnostic criteria.The patients' age,sex,risk factors,medical history,admission NIHSS score,two-week follow-up NIHSS score,90d follow-up mRS score and other case data were collected.And do ECG,head CT/MRI,head CTA/MRA and other tests.The patients were randomized into two groups,the dual antiplatelet therapy group was given clopidogrel(first day loading dose of 300mg the next day 75mg/d)plus aspirin(100 mg/d)for 14 days,and then changed to aspirin monotherapy(aspirin 100mg/d)to 90 days,Aspirin monotherapy group was given aspirin(300mg/d)for 14 days,and then changed to aspirin monotherapy(aspirin 100mg/d)to 90 days.The two-week follow-up NIHSS score and the 90-day follow-up mRS score were compared between the two groups.Statistical analyses were performed with the software package of SPSS 17.0,with p<0.05 considered statisitically efficient.Results:1.130 patients with mild to moderate acute non-cardiogenic cerebral infarction were selected.2.NIHSS scores after 14 days of treatment and mRS scores after 90 days of treatment were compared between two groups:The NIHSS score and the mRS score after 90 days of the patients in the combination therapy were better than those given monotherapy,P<0.05,considered statisitically efficient.3.A comparison of stroke progression and recurrence during the 90-day period,patients who received the dual antiplatelet therapy had significantly fewer ischemic stroke recurrence events and neurological deterioration than those given aspirin monotherapy,P<0.05,considered statisitically efficient.4.In the safety assessment,incidence of hemorrhage was similar between these two groups,P>0.05,there was no statistical significance.Conlusions:1.Compared with the aspirin monotherapy,the dual antiplatelet therapy is more effective in the treatment of mild to moderate acute non-cardiogenic ischemic stroke.2.Compared with the aspirin monotherapy,the dual antiplatelet therapy has a better prognosis for mild to moderate acute non-cardiogenic ischemic stroke,and there is no difference in safety.