Real-world study to idEntify patient characteristics inFLuencing the choice of statin dosE in individuals for primary Cardiovascular disease prevenTion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- To identify characteristics of primary CVD prevention patients ie those who do not have a history of atherosclerotic CVD as per the dose of statins
研究概览
简要总结
Statins are recognized as the first-line therapy for dyslipidemia management and for cardiovascular risk reduction. Major guidelines recommend use of statin therapy for both primary and secondary prevention of cardiovascular diseases. Specifically for primary cardiovascular disease prevention, the dose of statin depends on the assessment of cardiovascular risk. The risk defines the dose of statin to be prescribed. Evidence from India on the aspects that clinicians use to decide the dose of statin is sparse. Thus, REFLECT study has been undertaken to identify patient characteristics that influence the choice of statin dose in primary cardiovascular disease prevention individuals in real world setting
The recruitment of 15,000 patients will be facilitated by 750 investigators across India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary CVD prevention patients ie patients with no history of atherosclerotic cardiovascular disease CVD but with risk factors for developing CVD as assessed from the clinical history documentation of the patient Patients who are initiated on a statin rosuvastatin or atorvastatin within the last 6 months as per the clinical judgement of the treating physician and are continuing the same dose or and require a dose modification as per clinical judgement of the treating physician in the current visit and Patients who are willing to provide informed written consent and agree to comply with the study procedures.
排除标准
- •Patients with known history of hypersensitivity eg anaphylaxis or angioedema to any component active and any excipients of the prescribed product rosuvastatin or atorvastatin Women who are pregnant or breastfeeding during study period Patients with acute liver failure or decompensated cirrhosis Patients who are participating in another clinical study.
结局指标
主要结局
To identify characteristics of primary CVD prevention patients ie those who do not have a history of atherosclerotic CVD as per the dose of statins
时间窗: Single Visit
rosuvastatin 5mg or 10mg or 20mg or 40mg
时间窗: Single Visit
and atorvastatin 10mg or 20mg or 40mg or 80mg
时间窗: Single Visit
次要结局
- To analyse the association between the LDL C levels with dose of statin rosuvastatin or atorvastatin in patients already initiated on a statin rosuvastatin or atorvastatin
研究者
Dr Ashok Kumar Das
Cipla Limited