RESUMO
BACKGROUNDS: Embolic stroke is one of the main mechanisms of ischaemic stroke. Even if treated with recommended antithrombotic agents, stroke recurrence remains high. The Shuxuetong injection, a purified extract of traditional Chinese medicine widely used for thrombus diseases in clinical practice in China, could be a promising agent to prevent stroke recurrence. AIMS: To describe the design of the Shuxuetong injection for prevention of recurrence in acute ischaemic stroke with embolism mechanisms. DESIGN: The Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial is a multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial to evaluate the efficacy and safety of Shuxuetong injection in reducing recurrence or silent new ischaemic lesions on patients with acute embolic stroke within 10 days. An estimated 2416 patients with embolic stroke within 72 hours of symptom onset from 80 hospitals will be randomly assigned to one of two groups receiving Shuxuetong injection or placebo injection for 10 days. The primary endpoint is symptomatic or asymptomatic new cerebral infarction within 10 days after randomisation. CONCLUSION: The SPACE Trial will provide valuable evidence for the efficacy and safety of Shuxuetong injection for the prevention of stroke recurrence in patients with imaging-defined embolic stroke. CLINICAL TRIAL REGISTRATION: NCT03090113.
Assuntos
Isquemia Encefálica/tratamento farmacológico , Medicamentos de Ervas Chinesas/administração & dosagem , Embolia Intracraniana/tratamento farmacológico , Prevenção Secundária , Acidente Vascular Cerebral/tratamento farmacológico , Adolescente , Adulto , Idoso , Isquemia Encefálica/diagnóstico , China , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Estudos de Equivalência como Asunto , Feminino , Humanos , Injeções , Embolia Intracraniana/diagnóstico , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Recidiva , Acidente Vascular Cerebral/diagnóstico , Resultado do Tratamento , Adulto JovemRESUMO
We investigated the usage of secondary prevention drugs and traditional Chinese medicine (TCM) products in individuals with cardiovascular diseases (CVDs) at the community level in China. Among 2,407 participants with self-reported coronary heart disease (CHD) and 872 with stroke, nearly 80% of individuals with CHD and 73% of individuals with stroke were not taking any proven secondary prevention drug. However, 32.9% of them took TCM products. Patients with CVDs in rural areas used less secondary prevention treatment, but more TCM products than their counterparts in the urban regions. After adjusting for confounding factors, lower rates of secondary prevention treatment were evident in Western China compared with Eastern China, which was more developed. Systematic change is needed to promote the development of evidence-based medicine at the community level in China.