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) 目前中风的发病率和患病率最高 目前的预测是，世界上最糟糕的中风生存结果已经是压倒性的。 非洲的中风和其他心血管疾病（CVD）负担将在未来继续升级 几十年来，传统的血管危险因素确实在这些人群中迅速兴起。 是非洲中风的前 2 个可改变危险因素，人口归因比例分别为 90.2% 和 35.8%， 分别将它们定位为减少中风后继发风险的主要目标。 降低中低收入国家 (LMIC) 的血管风险将实现减少慢性病的全球目标 疾病死亡率每年增加 2%，而加纳的医疗支出仅略有增加。 撒哈拉以南非洲地区的中低收入国家严重缺乏中风幸存者医疗保健协调人力资源，特别是 还实施基于证据的二级预防疗法。 称为“复方药”，含有非专利药物：阿司匹林、他汀类药物和降血压药物， 可能是一种可行的低成本途径，可以广泛提高药物依从性，从而进一步减少 SSA 中风幸存者的大规模残疾或死亡因此，中风的总体目标。 在常规治疗 II (SMAART-II) 研究中通过添加抗动脉粥样硬化药物最小化 混合研究设计，1) 证明含有固定剂量的复方药 (Polycap®) 的功效 抗高血压药、他汀类药物和抗血小板治疗，每次服用两粒胶囊，每天口服一次，以减少 500 名最近在 12 岁时遭遇中风的患者在 24 个月内的复合血管风险与常规护理的比较 加纳的医院；2) 制定 Polypill 常规整合和政策采用的实施策略 在资源匮乏、护理欠佳的系统中降低中风后心血管风险 SMART-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 拨款 (NS103752) 的支持下进行的一项单中心试验 (SMAART-I) 在加纳人中进行 来自美国国立卫生研究院全球脑部疾病项目的研究人员现在正在寻求测试复方药丸的明确功效和安全性。 改善有意义的中风后全球风险因素控制，在更大的样本中，跨多个地点，跨 多样化的医疗保健环境，超越三级护理，并且除了评估临床之外。 成果，SMAART II 将评估实施成果，例如采用、可接受性、成本、相关 无论其结果如何，加纳采用 Polypill 策略来为政策提供信息，SMAART-II 的研究结果。 将从非洲的角度提供有意义的信息，为制定指导方针提供信息 国际机构（例如， 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