The SCCS Polypill Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Medication Adherence-Percentage of Pills Taken
研究概览
简要总结
In this study the investigators will examine the effect of the polypill on medication adherence, systolic blood pressure, and LDL cholesterol over a 12 month span.
详细描述
The purpose of this study is to assess if a polypill-based approach to primary CVD prevention is feasible in a low socioeconomic status population. The study will assess whether a polypill approach is associated with better cardiovascular risk factor control compared with usual care.
The polypill will be supplied as a compounded pill containing atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg. The medications in the polypill have been extensively evaluated individually and in combination. Each of the medications in the polypill is approved by the United States Food and Drug Administration (FDA) and widely administered in the US for the treatment of and prevention of cardiovascular disease. The doses of each component medication included in the polypill are low, which should minimize the chance of any potential side-effects.
In this study we assess medication adherence, systolic blood pressure, and LDL cholesterol over a 12 month span, in subjects taking the polypill versus subjects under usual care.
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
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled at the SCCS site in Mobile, Alabama, obtain care at Franklin Primary Health Center, or live in the surrounding area.
- •Aged 45-75 years
- •Baseline systolic blood pressure ≥120 mm Hg. In this open-label trial, the study physicians are permitted to prescribe any additional medication deemed appropriate to achieve blood pressure control.
排除标准
- •History of coronary heart disease or stroke
- •History of cancer, except for basal cell skin cancer
- •History of liver disease, not including chronic, clinically-stable hepatitis
- •Laboratory evidence of hepatic dysfunction (an alanine aminotransferase level more than two times the upper limit of the normal range)
- •Known renal disease, estimated creatinine clearance < 60
- •Current use of more than 2 anti-hypertensive medications
- •LDL cholesterol ≥190 mg/dl
- •Insulin-dependent diabetes
- •Known intolerance to any of the components of the polypill
- •Potassium <3.4 or >5.5 mEq/L
- •Use of medications that interact with statins, including those affecting the cytochrome P450 system
- •Current use of diuretics for indications other than hypertension
- •Comorbidities that might be expected to limit lifespan during the 12-month follow-up period
- •Inability to provide consent.
研究组 & 干预措施
Polypill
The study medication will be a fixed-dose combination pill (polypill) containing: Atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg.
Polypill will be taken once daily.
干预措施: Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide) (Drug)
结局指标
主要结局
Medication Adherence-Percentage of Pills Taken
时间窗: 12 months
polypill arm-evaluation via pill counts.
LDL Cholesterol
时间窗: 12 months
Polypill versus usual care
Systolic Blood Pressure
时间窗: 12 months
polypill versus usual care
次要结局
- Systolic Blood Pressure(2 months)
- LDL Cholesterol(2 months)
- Medication Adherence(2 months)
- Drug Metabolite Profile(12 months)
- Insulin Resistance(Baseline and 12 months)
- Inflammatory Profile(Baseline and 12 months)
研究者
Thomas Wang
Director of the Division of Cardiovascular Medicine
Vanderbilt University