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

通过在常规治疗中添加抗动脉粥样硬化药物来最大限度地减少中风 II 研究

• 批准号: 10539167
• 负责人: BRUCE OVBIAGELE
• 金额: $ 53.22万
• 依托单位: NORTHERN CALIFORNIA INSTITUTE/RES/EDU
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10539167
• 关键词: Acute; Adherence; Adoption; Africa; Africa South of the Sahara; African; Age; Antihypertensive Agents; Aspirin; Blood Pressure; Blood Vessels; Brain Diseases; Cardiac Death; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Cholesterol; Chronic Disease; Clinical; Clinical Trials; Consultations; Country; Data; Death Rate; Dose; Dyslipidemias; Enrollment; Event; Formulation; Generic Drugs; Ghana; Goals; Grant; Guidelines; Health Expenditures; Health system; Healthcare; Hospitals; Human Resources; Hybrids; Hypertension; Incidence; International; Ischemic Stroke; Knowledge; LDL Cholesterol Lipoproteins; Measures; Medical; Medical center; Myocardial Infarction; Neurologist; Oral; Outcome; Outcome Measure; Participant; Patients; Persons; Pharmaceutical Preparations; Phase; Policies; Population; Population Attributable Risks; Positioning Attribute; Prevalence; Prevention; Prevention Guidelines; Prevention therapy; Quality of life; Randomized Clinical Trials; Recurrence; Regimen; Research; Research Design; Resource-limited setting; Resources; Risk; Risk Factors; Risk Reduction; Safety; Sampling; Secondary Prevention; Serum; Site; Standardization; Stroke; System; Testing; United States National Institutes of Health; Ursidae Family; World Health Organization; adjudicate; adverse outcome; arm; capsule; cardiovascular disorder risk; cardiovascular risk factor; care coordination; care outcomes; carotid intima-media thickness; clinical care; cost; disability; effectiveness evaluation; evidence base; experience; health care settings; high risk; implementation barriers; implementation evaluation; implementation facilitators; implementation outcomes; implementation strategy; improved; low and middle-income countries; medication compliance; modifiable risk; mortality; pill; post stroke; primary outcome; programs; routine care; safety and feasibility; stroke incidence; stroke outcome; stroke patient; stroke survivor; survival outcome; treatment as usual; uptake; usual care arm; vascular risk factor

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.

全球估计表明，撒哈拉以南非洲（SSA）目前中风的发病率和患病率最高 也是世界上中风存活率最差的目前的预测是， 在未来一段时间内，非洲的中风和其他心血管疾病（CVD）负担将继续升级， 几十年来，传统的血管危险因素在这些人群中不断增加。事实上，高血压和血脂异常 是非洲卒中的前2大可改变风险因素，人群归因分数分别为90.2%和35.8%， 分别将其定位为卒中后继发性风险降低的主要目标。确定战略， 降低低收入和中等收入国家（LMIC）的血管风险将实现降低慢性阻塞性肺疾病的全球目标。 疾病死亡率每年增加2%，而卫生支出仅略有增加。加纳是一个 南撒哈拉地区的低收入国家严重缺乏中风幸存者的卫生保健协调人力资源， 在实施循证二级预防疗法方面。固定剂量的复合药丸，也 被称为“聚药丸”，含有仿制药：阿司匹林、他汀类药物和降低血压（BP）的药物， 可能是一种可行的低成本途径，以广泛改善药物依从性， 残疾或死亡的大规模中风幸存者在SSA。因此，中风的总体目标 常规治疗II（SMAART-II）研究中通过添加抗动脉粥样硬化药物实现最小化 混合研究设计：1）证明含有固定剂量的 抗高血压药、他汀类药物和抗血小板治疗，以两粒胶囊形式服用，每日一次口服， 500例12岁时发生的近期卒中患者中24个月的复合血管风险与常规治疗的比较 加纳的医院; 2）制定Polypill常规整合和政策采纳的实施战略 在资源不足的系统中降低卒中后心血管风险， 结果。SMAART-II对Polycap ®治疗缺血性卒中的可行性和相对安全性进行了评估 在加纳人中进行的一项单中心试验（SMAART-I），该试验在R21资助（NS 103752）的支持下进行 来自NIH全球脑疾病项目。我们现在试图测试复方药片的确切疗效和安全性 在更大的样本中，在多个研究中心， 在三级保健之外，在较长的时期内，提供多样化的保健环境。除了评估临床 结果，SMAART II将评估实施结果，如采用、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的发现 将从非洲的角度提供有意义的信息，为制定指导方针提供信息， 国际机构在全球范围内将聚药丸纳入二级心血管疾病风险预防的常规护理， 即世界卫生组织。