Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Carotid Intimal Media Thickness
研究概览
简要总结
The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is to assess whether a polypill containing fixed doses of (2/3) antihypertensives, a statin and antiplatelet therapy taken once daily orally would result in carotid intimal thickness regression-a surrogate marker of atherosclerosis, improved adherence, and tolerability compared with 'usual care' group on separate individual secondary preventive medications among Ghanaian first time stroke survivors. Our ultimate objective is to design of a future multi center, double-blinded, placebo-controlled, parallel-group, 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 polypill for CVD risk moderation among stroke survivors in LMICs. In this current study, we plan to recruit 120 recent ischemic stroke survivors randomized 1:1 to the polypill or usual care arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above the age of 18 years; male or female
- •Stroke/TIA diagnosis no greater than two months before enrollment. Ischemic strokes including lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible -
- •Subjects with stroke may present with at least one of the following additional conditions: Documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension >140/90mmHg or previous treatment with anti-hypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction
- •Legally competent to sign informed consent
排除标准
- •Unable to sign informed consent
- •Contraindications to any of the components of the polypill
- •Hemorrhagic stroke
- •Severe cognitive impairment/dementia or severe global disability limiting the capacity of self-care
- •Severe congestive cardiac failure (NYHA III-IV)
- •Severe renal disease, eGFR <30ml/min/1.73m2), renal dialysis; awaiting renal transplant or transplant recipient
- •Cancer diagnosis or treatment in past 2 years
- •Need for oral anticoagulation at the time of randomization or planned in the future months
- •Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation)
- •Nursing/pregnant mothers
- •Do not agree to the filing, forwarding and use of his/her pseudonymized data.
研究组 & 干预措施
Polypill
Assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule
干预措施: Polycap (Drug)
结局指标
主要结局
Carotid Intimal Media Thickness
时间窗: Baseline and 12 months
Thickness of the intima and media layers of the carotid arteries
次要结局
- Morisky Adherence Scale Score(12 months)
- Hill-Bone Score(12 months)
- EQ-5D Quality-of-Life Score(12 months)
- Treatment Satisfaction Questionnaire for Medication Score(12 months)
- Montreal Cognitive Assessment Score(12 months)
- Modified Rankin Score(12 months)
- Hamilton Rating Scale for Depression Score(12 months)
研究者
Bruce Ovbiagele
Chair, Neurology
Northern California Institute of Research and Education