Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Composite vascular risk factor control
研究概览
简要总结
The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, 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 1000 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- •Ischemic stroke 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 antihypertensive 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
Intervention
Patients allocated to the experimental arm will receive Two (2) (Polycap ®) taken orally once a day. A capsule of Polycap ® contains 100mg of Aspirin, 20mg of simvastatin, 12.5mg hydrochlorothiazide, 5mg of ramipril and 50mg of atenolol. Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn & replaced with the Polypill if they are already receiving such treatments before enrollment.
干预措施: Polycap (Drug)
Control arm
Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention with drugs and doses left at the discretion of the treating physicians. Since our focus is to isolate the effect of the polypill strategy itself & create equipoise, at study inception providers for patients in both study arms will receive a brief one-time (Skype-based) training & a one time email synopsis on guideline recommended biomarker targets after stroke.
结局指标
主要结局
Composite vascular risk factor control
时间窗: 12 and 24 months
Proportion of people who have 0, 1, 2 and 3 of the following: systolic BP \<140 mm Hg, LDL-cholesterol \<100mg/dl, antiplatelet adherence by pill count \>90%) at month 12 and month 24 (sustainment of effect)
次要结局
- Change in adherence to medical therapy(Month 3, 6, 9, 12, 18 & 24)
- Health-related quality of life EuroQol-5D(Up to 24 months)
- Major adverse cardiovascular events (MACE)(24 months)
- Safety and tolerability(Up to 24 months)
- Health-related quality of life Neuro-QoLTM(Up to 24 months)
研究者
Bruce Ovbiagele
Chief of Staff
Northern California Institute of Research and Education