NCT01313702撤回3 期
Effect of Polipill on Patients at High Cardiovascular Risk : a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- changed in blood pressure
研究概览
简要总结
The purpose of this study is to determine whether a polipill improved the compliance with treatment compared to usual care that use two or more drugs,in patients at high cardiovascular risk or previous cardiovascular disease.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults age ≥ 18 years old;
- •Patient that could written informed consent;
- •Patient with current atherothrombotic cardiovascular disease or at high cardiovascular risk, defined as:
- •Patients with previous Coronary Artery Disease (miocardial Infarction, estable or instable angina pectoris or coronary revascularization procedures);
- •Patients with previous miocardial Infarction, defined as medical registry (with documentation of at least 2 criterias: clinical symptoms,patological electrocardiogram and elevation of cardiac enzymes- CK-MB and/or troponin);
- •Patients with previous brain ischemia (stroke or transient ischemic attack)
- •Patients with confirmed previous peripheral arterial disease (Coronary Artery Bypass procedures or angioplasty or amputation due peripheral arterial disease)
- •Patients with no established cardiovascular disease but at high cardiovascular risk, defined as 15% or more in 5 years (using the Anderson Framingham scale, 1991)
排除标准
- •contraindication for any of the polipill
- •If the physician opinion is that terapeutical change could harm the patient (for example, heart failure, need of high beta blocker dose for treatment angina symptons and for the atrial fibrillation rhythm,severe hypertension [degree 3], malignant hypertension or renal insufficiency
- •Acute clinical conditions/ surgeries
- •Psychiatry clinical conditions(for example, schizophrenia, serious depression)
- •pregnant or lactation women
- •women at fertile period mulheres not using effective contraceptive methods (oral contraceptive, condom, intrauterine device)
- •liver siseases (AST/ALT/FA upon 3 x normal superior limits / bilirrubin upon 1,5 X normal superior limits / diagnosed Liver Cirrhosis
- •Renal disfunction (any laboratorial exams upon 3 x normal superior limits)
- •Previous participation on other clinical trial
- •The participant is unable or refuse to give informed consent.
研究组 & 干预措施
polipillV1
Experimental
poli pill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg
干预措施: polipillV1 (Drug)
polipillV2
Experimental
Polipill versão2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.
干预措施: polipillV2 (Drug)
usual care
Active Comparator
干预措施: usual care (Drug)
结局指标
主要结局
changed in blood pressure
时间窗: 18 months
compliance with treatment
时间窗: 18 months
changes in LDL-cholesterol levels
时间窗: 18 months
次要结局
- safety of poli pill measures by laboratorial tests(18 months)
- combined outcome(18 months)
- the main reason for non compliance with treatment(18 months)
研究者
研究点 (1)
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