The Feasibility of a Polypill Clinical Trial for Primary Prevention of Cardiovascular Disease: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 3
- 主要终点
- Reduction of the Estimated 10-year Total Cardiovascular Risk Score
研究概览
简要总结
The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). We hypothesized that A "polypill" comprising the aforementioned four components would significantly reduce the estimated 10-year total CVD risk score with high adherence and no significant increase in adverse effects compared to the standard practice.
详细描述
This is an open-label, parallel-group, randomized clinical trial comparing a Polypill to Standard Practice (defined as usual care administered to patients with similar conditions). Approximately 200 participants will be recruited from three sites in Sri Lanka: The National Hospital of Sri Lanka, Colombo; Teaching Hospital, Kegalle, and Teaching Hospital, Kandy. Subsequent to granting written informed consent, patients will undergo screening and baseline evaluation to confirm eligibility, followed by randomization to the Polypill or to the Standard Practice study arm. Patients receiving either intervention will return for a total of three monthly clinic visits.
Physician acceptability will be evaluated through a five-question survey will be mailed to a random sample of physicians from the participating clinical sites and to the Council of General Practitioners in Sri Lanka.
Patient acceptability will be measured in participants who will complete the study as well as those who will be screened but not eligible
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated 10-year total CVD risk score > 20%. The total CVD risk assessment will be based on the recently developed WHO CVD risk prediction charts
- •No contraindication for treatment with aspirin, angiotensin converting enzyme inhibitors, low-dose diuretics, or statins
- •Informed consent given
排除标准
- •Patients with established angina pectoris, coronary heart disease, myocardial infarction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and/or carotid endarterectomy Left ventricular hypertrophy (on ECG) or hypertensive retinopathy (grade III or IV)
- •Patients with secondary hypertension
- •Patients with diabetes type 1 or 2 with overt neuropathy or other significant renal disease.
- •Known renal failure or impairment
- •Atrial fibrillation
- •ALT > 1.5 times the upper limit of normal
- •History of liver cirrhosis or hepatitis
- •History of recent gastrointestinal bleeding (within the last year)
- •Women in child bearing period
- •History of life-limiting diseases or events
- •Unwillingness to sign informed consent.
研究组 & 干预措施
The Red Heart Pill 2b (Polypill) (A)
The Polypill is composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide
干预措施: Red Heart Pill 2b (Polypill) (Drug)
Standard Practice Group (B)
Standard Practice
干预措施: Standard Practice (Other)
结局指标
主要结局
Reduction of the Estimated 10-year Total Cardiovascular Risk Score
时间窗: Six months
Estimated 10-year CVD total risk score were calculated in the field centers and in the Coordinating Center from the measures of blood pressure and total cholesterol and from the medical history data collected during each visit using the WHO CVD prediction chart. The estimated 10-year CVD total risk calculated by the Coordinating Center were used for analysis. the score is based on systolic blood pressure and total cholesterol measures as well as on medical history data (monthly). Each one of these risk factors is assigned a point in the score and then linked to a table that mention the calculated CVD risk
次要结局
未报告次要终点