Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >70 Years: the SCOPE-70 RCT Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 724
- 试验地点
- 1
- 主要终点
- Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.
研究概览
简要总结
One of the most effective drug in the primary prevention of cardiovascular disease is statins. The protective effects of statin on developement of cardiovascular disease has been demonstrated in elderly individuals. Since side effects of statin are more common in elderly individuals than in younger individuals, clinical guidelines recommend that use of low intensity statin is considered in elderly individuals. However, there are few randomized clinical trials evaluating the safety and efficacy of different intensity statins in elderly individuals.
This is a multicenter, prospective, randomized clinical trial to compare efficacy and safety between low and high intensity statin for primary prevention of cardiovacsular disease in elderly individuals.
详细描述
This study is a multicenter, prospective, randomized clinical trial evaluating the safety of low-intensity statins versus moderate-intensity statins in the primary prevention of cardiovascular disease in elderly patients aged 70 years or older without cardiovascular disease. The patient recruitment period is 2 years, with a 6-month follow-up period (a 4-year follow-up is optional).
Individuals deemed eligible through screening will be randomly assigned in a 1:1 ratio to either the rosuvastatin 2.5mg or rosuvastatin 10mg group. After randomization, subjects will visit at 3 and 6 months for scheduled blood tests, physical examinations, and questionnaires regarding muscle symptoms. After 6 months, subjects may optionally continue routine primary cardiovascular disease prevention care for a total of 4 years of follow-up.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Low intensity statin group
Taking low intensity statin
干预措施: Low intensity statin (Drug)
Moderate intensity statin group
Taking moderate intensity statin
干预措施: Moderate intensity statin (Drug)
结局指标
主要结局
Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.
时间窗: 6 months
1. They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise. 2. These symptoms have persisted for at least 2 weeks. 3. The symptoms resolve within 2 weeks of stopping the study drug. 4. The symptoms reoccur within 4 weeks of restarting the medication.
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).
时间窗: 6 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)
时间窗: 6 months
次要结局
- Clinical outcomes(4 years for MACE. 6 months for all adverse events.)