Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II Study

全球估计表明，撒哈拉以南非洲(SSA)现在中风的发病率和流行率最高 也是世界上中风导致的最糟糕的生存结果。目前的预测是，已经势不可挡的 未来几年，非洲中风和其他心血管疾病的负担将继续上升 几十年来，传统的血管危险因素在这些人群中萌芽。的确，高血压和血脂异常 是非洲中风的前两个可改变的危险因素，人口归因率分别为90.2%和35.8%， 分别将它们定位为卒中后二次风险降低的主要目标。确定战略，以 在低收入和中等收入国家(LMIC)降低血管风险将实现减少慢性疾病的全球目标 疾病死亡率每年增加2%，卫生支出仅有温和增长。加纳是一个 南沙的LMIC严重缺乏人力资源来协调中风幸存者的医疗保健，特别是 在实施循证二级预防疗法方面。固定剂量的联合药片，也 被称为“复方药”，包含仿制药：阿司匹林、他汀类药物和降血压药物(S)， 可能是一种可行的低成本途径，可以广泛改善服药依从性，从而进一步减少 在SSA的中风幸存者中，残疾或死亡的规模很大。因此，中风的总体目标是 在常规治疗II(SMAART-II)研究中通过添加抗动脉粥样硬化剂将其降至最低 一项混合研究设计，以1)证明含有固定剂量的 降压药、他汀类药物、抗血小板治疗分两次服用，每日一次口服，减少 500名12岁新发中风患者24个月内的综合血管风险与常规护理的对比 加纳的医院；2)为Polypill的常规整合和政策采纳制定执行战略 用于在资源不足的系统中降低中风后心血管风险，该系统由次优护理和 结果。SMAART-II的前提是PolyCap®治疗缺血性中风的可行性和相对安全性 在R21赠款的支持下进行的单中心试验(SMAART-I)中的加纳人(NS103752) 来自美国国立卫生研究院全球大脑紊乱项目。我们现在寻求测试保健片的最终疗效和安全性。 在跨多个地点的更大样本中改善有意义的卒中后全球风险因素控制 不同的卫生保健环境，超越三级保健，而且持续时间更长。除了评估临床 结果，SMAART II将评估实施结果，如采用率、可接受性、成本、与 在加纳采用Polypill战略，为政策提供信息。无论结果如何，SMAART-II的研究结果 将从非洲的角度提供有意义的信息，为制定 国际机构在全球范围内将聚磷脂纳入二级心血管疾病风险预防的常规护理，例如 世界卫生组织。

Global estimates suggest that sub-Saharan Africa (SSA) now has the highest incidence and prevalence of stroke and the worst survival outcomes from stroke in the world. Current projections are that the already overwhelming burden of strokes and other cardiovascular diseases (CVDs) in Africa will continue to escalate over the coming decades as traditional vascular risk factors burgeon in these populations. Indeed, hypertension and dyslipidemia are the top 2 modifiable risk factors for stroke in Africa with population attributable fractions of 90.2% and 35.8%, respectively, positioning them as prime targets for secondary risk reduction after stroke. Identifying strategies to reduce vascular risk in Low-and Middle-Income Countries (LMICs) will meet a global goal of reducing chronic disease death rates by an additional 2% per year, with only a moderate rise in health expenditures. Ghana is a LMIC in SSA with a profound lack of human resources for health care coordination for stroke survivors, especially in the implementation of evidence-based secondary prevention therapies. Fixed-dose combination pills, also known as “polypills”, containing generic drugs: aspirin, a statin, and blood pressure (BP) lowering medication(s), may be a viable low-cost avenue to broadly improve medication adherence and consequently reduce further disability or death on a large scale among stroke survivors in SSA. Therefore, the overall objective of Stroke Minimization through Additive Anti-atherosclerotic agents in Routine Treatment II (SMAART-II) study is to deploy a hybrid study design to 1) demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 500 recent stroke patients encountered at 12 hospitals in Ghana; 2) develop an implementation strategy for routine integration and policy adoption of Polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes. SMAART-II is premised on the feasibility and relative safety of the Polycap ® for ischemic stroke among Ghanaians in a single center trial (SMAART-I) conducted with the support of an R21 grant (NS103752) from the NIH Global Brain Disorders program. We now seek to test the definitive efficacy and safety of the polypill to improve meaningful post-stroke global risk factor control in a larger sample, across several sites, across diverse health care settings, beyond tertiary level care, and over a longer period. In addition to assessing clinical outcomes, SMAART II will assess implementation outcomes such as adoption, acceptability, cost, pertinent to uptake of the Polypill strategy in Ghana to inform policy. Regardless of its outcome, findings from SMAART-II will contribute meaningful information from the African perspective to inform the formulation of guidelines for global adoption of polypills into routine care for secondary CVD risk prevention by international bodies such as the World Health Organization.