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: 10686912
• 负责人: BRUCE OVBIAGELE
• 金额: $ 51.11万
• 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/10686912
• 关键词: Acute; Adherence; Adoption; Africa; Africa South of the Sahara; African; Age; Antihypertensive Agents; Aspirin; Blood Platelets; Blood Pressure; Blood Vessels; Brain Diseases; Cardiac Death; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Cholesterol; Chronic Disease; Clinical Trials; 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; Recommendation; 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; World Health Organization; adjudication; adverse outcome; arm; capsule; cardiovascular disorder risk; cardiovascular risk factor; care coordination; carotid intima-media thickness; clinical care; clinical outcome assessment; cost; disability; effectiveness evaluation; efficacy 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; randomized, clinical trials; 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）现在的中风发生率最高和患病率 以及世界上中风的最糟糕的生存结果。当前的项目是已经压倒了 非洲的中风和其他心血管疾病（CVD）的负担将继续升级 在这些人群中，数十年是传统的血管危险因素。确实，高血压和血脂异常 是非洲中风的前两个可修改风险因素，人口归因于90.2％和35.8％的人口。 分别将它们定位为中风后次要风险降低的主要目标。确定策略 降低低收入和中等收入国家（LMIC）的血管风险将达到减少慢性的全球目标 疾病死亡率每年增加2％，只有现代的健康支出增加。加纳是一个 LMIC在SSA中，严重缺乏人力资源来实现中风生存的医疗保健协调，尤其是 在实施基于证据的二级预防疗法中。固定剂量组合药也 被称为“ polypills”，含有通用药物：阿司匹林，他汀类药物和血压（BP）降低药物， 可能是一个可行的低成本大道，可以广泛改善药物依从性并因此进一步减少 SSA中风幸存者中的残疾或死亡。因此，中风的总体目标 通过常规治疗中的添加剂抗动脉粥样硬化剂最小化II（SMAART-II）研究是部署 杂种研究设计至1）证明了含有固定剂量的polypill（polycap®）的效率 每天口服一次降压剂，他汀类药物和抗血小板疗法作为两个胶囊 在24个月内的复合血管风险与通常的500名中风患者相比，在12岁时遇到的平常护理 加纳的医院； 2）制定polypill的常规整合和政策采用的实施策略 对于中风后心血管风险的降低，在次优的护理中燃烧的资源不足的系统中 结果。 SMAART-II以缺血性中风的可行性和相对安全性为前提 在R21赠款（NS103752）的支持下，在一个中心审判（SMAART-I）中，在加纳人中 来自NIH全球脑疾病计划。现在，我们试图测试波普尔的确定效率和安全性 为了改善较大样本的有意义的中风后全球风险因素控制，跨多个站点，跨越 多样化的医疗保健环境，超越三级护理以及更长的时间。除了评估临床 结果，Smaart II将评估采用，可接受性，成本等实施成果，与 加纳的Polypill战略采用了为政策提供信息。无论其结果如何，Smaart-II的发现 将从非洲的角度贡献有意义的信息，以告知指南的公式 全球采用polypills参加常规护理，以预防国际机构的次级CVD风险。 世界卫生组织。

项目成果

A cardiovascular polypill for secondary stroke prevention in a tertiary centre in Ghana (SMAART): a phase 2 randomised clinical trial.

• DOI: 10.1016/s2214-109x(23)00347-9
• 发表时间: 2023-10
• 期刊: LANCET GLOBAL HEALTH
• 影响因子: 34.3
• 作者: Sarfo, Fred Stephen;Voeks, Jenifer;Adamu, Sheila;Agyei, Benedict Apaw;Agbenorku, Manolo;Adu-Darko, Nyantakyi;Oteng, Mercy Adomah;Obese, Vida;Gyamfi, Rexford Adu;Mensah, Nathaniel Adusei;Tagge, Raelle;Ampofo, Michael;Kontoh, Samuel Amoabeng;Nguah, Samuel Blay;Ovbiagele, Bruce
• 通讯作者: Ovbiagele, Bruce