A Single-center Prospective Randomized Study of Atorvastatin in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of platelet response
研究概览
简要总结
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of atorvastatin for the treatment of adults with immune thrombocytopenia (ITP).
详细描述
The investigators anticipate to undertaking a parallel group, single-centre, randomised controlled trial of 30 ITP adult patients, which have no indications of glucocorticoid therapy (platelets count > 30*10^9/L )from Qilu Hospital of Shandong University in China.15 of the participants are randomly selected to receive atorvastatin in 20 mg/d combining with 10 mg/d for 6 months. Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of atorvastatin for the treatment of adults with ITP.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for immune thrombocytopenia.
- •within 3 months from diagnosis,untreated patients, may be male orfemale, between the ages of 18 ~ 80 years.
- •To show a platelet count > 30×10^9/L and without bleeding manifestations.
排除标准
- •Received chemotherapy or anticoagulants or other drugs affecting theplatelet counts within 3 months before the screening visit.
- •Received steroids or other effective therapy for immune thrombocytopenia.
- •Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- •Severe medical condition (lung, hepatic or renal disorder) other than ITP.
- •Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- •Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- •Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- •Patients who are deemed unsuitable for the study by the investigator.
研究组 & 干预措施
AT with 10 mg/d
The patients will be given receive atorvastatin in 10 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.
干预措施: Atorvastatin 10mg (Drug)
AT with 10 mg/d
The patients will be given receive atorvastatin in 10 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.
干预措施: Dexamethasone (Drug)
AT with 20 mg/d
The patients will be given atorvastatin in 20 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.
干预措施: Atorvastatin 20mg (Drug)
AT with 20 mg/d
The patients will be given atorvastatin in 20 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.
干预措施: Dexamethasone (Drug)
Dexamethasone
The patients will be given dexamethasone 40mg/d for 4 days.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Evaluation of platelet response
时间窗: up to 1 year per subject
Platelet count will be observed at 1 month, 3 months, 6 months and 12 months after atorvastatin therapy
次要结局
- Therapy associated adverse events(up to 1 year per subject)
研究者
Ming Hou
Professor and Director
Shandong University