Real World Research Based on Genomics: Comparison of Precision and Experience Therapy for Chronic Cardiovascular and Cerebrovascular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,172
- 试验地点
- 2
- 主要终点
- change of low density lipoprotein cholesterol
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness, safety and health economics of precise drug use strategies based on pharmacogenomics compared with traditional drug use strategies for cardiovascular related chronic diseases.
详细描述
This study is a randomized controlled, single blind, multicenter clinical study. Beijing Chaoyang Hospital is the team leader, and director Liu Lihong is the project leader. The sub center is Daming County Street Town Health Center and Daming County Jiuzhi township health center. The team leader is responsible for the formulation, implementation and coordination of the research plan, and each sub center is responsible for the implementation of the specific study, patient management and research information feedback.
Three project groups were set up in this study: primary hypertension, type 2 diabetes and hyperlipidemia. In each group, the control group and the experimental group were set up, and the patients in two pilot towns of Daming County were selected by cluster stratified random sampling. The control group received the treatment of local researchers according to the traditional medication strategy. The patients in the experimental group were treated with the drug regimen formulated by local researchers according to the results of their pharmacogenomic test reports. The subjects were single blind.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They are 55 years old or above, with no gender restriction. They are permanent residents of Da-jie town and Jiu-zhi Township in Da-ming County.
- •Patients who meet one of the following:
- •A. Hypertension project group:
- •Primary hypertension was definitely diagnosed, systolic blood pressure ≥ 140 millimeter of mercury, diastolic blood pressure ≥ 90 millimeter of mercury, or both after drug treatment.
- •B.Type 2 Diabetes project group:
- •Patients with type 2 diabetes mellitus (non insulin dependent diabetes mellitus) who were diagnosed as type 2 diabetes mellitus (NIDDM) and had HbA1c ≥ 7.0% after drug treatment before enrollment.
- •C.Hyperlipidemia project group:
- •Those who were diagnosed as hyperlipidemia and were treated with or without medication before enrollment.
- •Patients who can provide real and reliable information related to drug treatment and efficacy evaluation
排除标准
- •Respondents who are not willing to fill in the true and reliable information form for any reason.
- •Patients with infectious diseases or serious life-threatening diseases such as malignant tumors.
- •Patients with severe liver and kidney function damage, affecting the choice of treatment drugs.
- •Patients with incomplete data related to study evaluation such as any of following:
- •A.The clinical data did not include systolic blood pressure, diastolic blood pressure, heart rate, glycosylated hemoglobin, fasting blood glucose, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride core efficacy evaluation indicators.
- •B.The data related to adverse reactions required by clinical research can not be collected, including but not limited to the related drugs with adverse reactions, adverse reaction performance, time correlation, whether to stop suspicious drugs, and whether to stimulate adverse reactions by re-medication.
- •C.The information of medication compliance score and quality of life score could not be provided for any reason.
结局指标
主要结局
change of low density lipoprotein cholesterol
时间窗: 3 months
Change of low density lipoprotein cholesterol from baseline
change of triglyceride
时间窗: 3 months
Change of triglyceride from baseline
change of total cholesterol
时间窗: 3 months
Change of total cholesterol from baseline
change of systolic pressure
时间窗: 3 months
Change of systolic blood pressure from baseline
change of diastolic pressure
时间窗: 3 months
Change of diastolic blood pressure from baseline
change of glycosylated hemoglobin
时间窗: 3 months
Change of glycosylated hemoglobin from baseline
change of fasting blood glucose
时间窗: 3 months
Change of fasting blood glucose from baseline
次要结局
- Compliance rate of blood pressure(12 months)
- Compliance rate of glycosylated hemoglobin(12 months)
- Compliance rate of low density lipoprotein cholesterol(12 months)
研究者
Lihong Liu
Professor
Beijing Chao Yang Hospital