Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART)

通过在常规治疗中添加抗动脉粥样硬化药物 (SMAART) 最大限度地减少中风

• 批准号: 9409079
• 负责人: BRUCE OVBIAGELE
• 金额: $ 16.04万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2018-08-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9409079
• 关键词: Adherence; Africa; Africa South of the Sahara; African; Age of Onset; Antihypertensive Agents; Aspirin; Atenolol; Blood Pressure; Blood Vessels; Caring; Case Fatality Rates; Cause of Death; Cessation of life; Clinic; Clinical Research; Consensus; Country; Data Analyses; Diabetes Mellitus; Diastolic blood pressure; Dose; Double-Blind Method; Drug Formulations; Drug usage; Dyslipidemias; Event; Fibrinolytic Agents; Future; Generic Drugs; Ghana; Goals; Guidelines; Health system; Hospitals; Hypertension; Income; Individual; International; Ischemic Stroke; LDL Cholesterol Lipoproteins; Lipids; Logistics; Medical; Mentorship; Neurologist; Neurology; Oral; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Placebo Control; Population; Prevalence; Prevention Guidelines; Preventive; Ramipril; Randomized; Recurrence; Research; Research Personnel; Resources; Risk; Risk Factors; Risk Reduction; Science; Secondary Prevention; Serum; Simvastatin; Site; Stroke; Stroke prevention; Survivors; System; Technology; Thick; United States National Institutes of Health; Universities; base; blood pressure reduction; capsule; career; cholesterol control; clinical care; clinical efficacy; cohort; cost; design; disability; evidence base; hazard; health literacy; high risk; improved; indexing; literacy; medication compliance; pill; pragmatic trial; randomized trial; response; stroke survivor; thiazide; treatment as usual; treatment strategy; trial comparing

SUMMARY/ABSTRACT There has been unprecedented rise in the prevalence of stroke in sub-Saharan Africa (SSA), which when compared to stroke profiles in high-income countries (HIC) is characterized by a younger age of onset, higher case fatality rates, and more severe disability among survivors. Stroke survivors in SSA (vs. HIC) are especially at high risk for recurrent vascular events or death due to undiagnosed or under-controlled vascular risk factors, logistical challenges, low health literacy, and lack of care affordability. While international expert consensus secondary prevention guidelines recommend that antihypertensive, statin and anti-platelet therapy, be initiated promptly after ischemic stroke and adhered to in a persistent fashion to achieve optimal vascular risk reduction, these goals are seldom realized in routine clinical care settings in SSA. A relatively simple, low-cost, evidence-based strategy that could be largely applied in a uniform manner to stroke survivors in low- to –middle income countries (LMICs), including the nations of SSA, is sorely needed. Fixed-dose combination pills, also known as “polypills”, containing generic drugs, i.e. Aspirin, a statin, and blood pressure (BP) lowering medication(s) may be a viable avenue to improve medication adherence and consequently reduce risk of further disability or death on a large scale among stroke survivors encountered in resource-constrained regions. The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is to determine the preliminary impact of a polypill (Polycap DS ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken once daily orally in reducing future vascular risk compared to usual care in 120 recent stroke patients seen at a hospital in Kumasi, Ghana, while preparing for a future large, multicenter pragmatic trial and building local research capacity. In SMAART, we will 1) evaluate whether a polypill-based treatment strategy would result in carotid intimal media thickness stabilization/regression compared with usual care among recent stroke patients at one year after an index ischemic stroke; 2) assess whether a polypill-based treatment strategy improves vascular risk reduction drug adherence and tolerability, as well as blood pressure and serum holesterol control targets, compared with usual care among recent stroke patients at one year after an index ischemic stroke; and 3) provide increased capacity for conducting clinical research and continuous mentorship to early stage career investigators in Ghana, and facilitate their transition to independent investigators capable of planning and executing rigorous randomized controlled for secondary stroke prevention and vascular risk reduction in a resource-limited setting. A preliminarily feasible and efficacy-suggesting SMAART trial will inform the design of a future multi-center, double-blinded, placebo-controlled, randomized trial comparing the clinical efficacy of the polypill strategy vs `usual care' in the African context to derive locally relevant, high-quality evidence for routine deployment of the polypill strategy for vascular risk moderation among stroke survivors in LMICs.

总结/摘要 撒哈拉以南非洲（SSA）的中风患病率出现了前所未有的上升，与 高收入国家（HIC）的卒中特征是发病年龄更小、病死率更高， 幸存者中的严重残疾。SSA（与HIC相比）的卒中幸存者复发血管事件的风险尤其高， 由于未确诊或控制不足的血管风险因素、后勤挑战、健康素养低和缺乏护理而导致的死亡 负担能力。虽然国际专家共识二级预防指南建议，抗高血压，他汀类药物， 和抗血小板治疗，应在缺血性卒中后立即开始，并以持续的方式坚持，以达到最佳的 血管风险降低，这些目标很少实现在常规临床护理设置在SSA。一种相对简单，低成本， 循证策略，可以在很大程度上以统一的方式应用于中低收入的中风幸存者 包括撒南非洲国家在内的中低收入国家（LMICs）非常需要。固定剂量的复合药丸，也被称为“聚药丸”， 含有仿制药，即阿司匹林、他汀类药物和降压药物可能是一种可行的途径， 改善药物治疗依从性，从而大规模降低中风患者进一步残疾或死亡的风险 在资源有限的地区遇到的幸存者。通过添加剂最小化卒中的总体目标 抗动脉粥样硬化药物常规治疗（SMAART）试验旨在确定复方制剂（Polycap）的初步影响 DS ®），包含固定剂量的抗高血压药、他汀类药物和抗血小板治疗，每日一次口服， 在加纳库马西的一家医院，120名最近的中风患者在准备接受一次治疗时， 未来的大型、多中心、务实的试验和建设当地的研究能力。在SMAART中，我们将1）评估 与常规治疗相比，基于息肉的治疗策略将导致颈动脉内膜中层厚度稳定/消退 在缺血性卒中指数后一年对近期卒中患者的护理; 2）评估基于息肉的治疗是否 降低血管风险的策略改善了药物依从性和耐受性，以及血压和血清胆固醇 缺血性中风指数发生一年后，与近期中风患者的常规护理相比，控制目标;和3） 提供更大的能力，开展临床研究，并为早期职业研究者提供持续的指导， 加纳，并促进他们过渡到能够规划和执行严格的随机化的独立研究者 在资源有限的情况下，控制二级卒中预防和血管风险降低。初步可行， 疗效提示SMAART试验将为未来的多中心、双盲、安慰剂对照， 一项随机试验，在非洲背景下比较复方制剂策略与“常规护理”的临床疗效， 在卒中患者中常规部署复方制剂策略以降低血管风险的相关高质量证据 LMIC的幸存者。