Quality Enhancement Research Initiative (QERI) in the Dyslipidemia Management Strategy Involving Ezetimibe With Statin in High Risk Patients Who Have Not Achieved Recommended LDL Targets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,500
- 试验地点
- 1
研究概览
简要总结
This is a multi-center, open label observational study conducted over 26 weeks.
Approximately 2,500 high-risk patients with an elevated LDL-C level (> 2.5 mmol/L) will be enrolled. Patients meeting all inclusion criteria and having none of the exclusion criteria at Visit 1 (Screening) will be included in the study. Eligible patients that agree to participate and sign an informed consent will be treated with either statin therapy (increased or started or switched) or combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient.
After enrollment there are a total of three scheduled clinic visits. All patients will have vital signs measured as well as a brief physical examination performed at Visit 1 (Screening).
At Visit 2 (6 weeks) patients with LDL-C > 2.5mmol/L will be treated with either statin therapy increase or combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient.
At Visit 3 (12 -18 weeks) patients with LDL > 2.5 mmol/L will be treated with combination of statin and ezetimibe 10 mg as per Study Schematic (Table 1) in order to achieve the recommended target of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient.
At final Visit 4 (24-26 weeks) safety and efficacy of treatment will be reviewed. Following Visit 4 physicians will continue to treat these patients according to their clinical judgment.
详细描述
Overview This is a Quality Enhancement Research Initiative (QERI) whereby physicians are provided guidelines and easy to follow steps for their achievement..
Approximately 2,500 high-risk patients with an elevated LDL-C level (> 2.5 mmol/L) will be enrolled. Patients meeting all inclusion criteria and having none of the exclusion criteria at Visit 1 (Screening) will be included. Eligible patients that agree to participate and sign an informed consent will be treated with appropriate treatment optimization including the use of ezetimibe on achieving Study Schematics (Table 1).
After enrollment there are a total of three scheduled clinic visits. Physicians may assess the patient between visit 2 and 3 if maximization of statin therapy is required.
At Visit 2 (6 weeks) patients with LDL > 2.5mmol/L will be treated with either statin therapy (increased or started or switched) or combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient.
At Visit 3 (12-18 weeks) patients with LDL > 2.5 mmol/L will be treated with combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is male or female older 18 years of age.
- •Patients with a diagnosis of primary hypercholesterolemia and who are defined as being "high risk" (10-year risk of coronary artery disease greater than 20 % based on the Framingham model and history of cardiovascular disease or)
- •Patients who have not reached their recommended LDL-C target levels of 2.5 mmol/L while on a statin alone.
- •According to the judgment of the treating physician patient enrollment is in the best interest of the patient.
- •Patient agrees to participate and signs an informed consent allowing follow up and sharing of patient related data.
排除标准
- •Individuals with poor mental function, drug or substance abuse, or individuals with unstable psychiatric illnesses, which, in the opinion of the investigator, may interfere with optimal participation in the observational study. Alcoholic substance abuse would be defined as a patient with alcohol consumption > 14 drink per week. (A drink is: a can of beer, glass of wine, or single measure of spirits.)
- •Patients who have been treated with any investigational drug within 30 days prior to Visit
- •(If <30 days, contact the clinical monitor for a case-by-case evaluation.)
- •Patients with clinically significant concomitant illnesses of liver, muscle or kidney abnormalities.