Atorvastatin in Management of Newly Diagnosed ITP

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Single-center Prospective Randomized Study of Atorvastatin in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)

Conditions
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Immune Thrombocytopenia, Purpura, Thrombocytopenic

Intervention / Treatment
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* Drug: Atorvastatin 20mg
* Drug: Atorvastatin 10mg
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AT with 10 mg/d<br>The patients will be given receive atorvastatin in 10 mg/d for 1 month plus dexamethasone 40mg/d for 4 days. | Drug: Atorvastatin 10mg<br>* Atorvastatin will be given in 10 mg po qn for 1 month<br>* Other names: atorvastatin calcium;Drug: Dexamethasone<br>* Dexamethasone will be given in 40mg po qd for 4 days<br>|
| Active Comparator: AT with 20 mg/d<br>The patients will be given atorvastatin in 20 mg/d for 1 month plus dexamethasone 40mg/d for 4 days. | Drug: Atorvastatin 20mg<br>* Atorvastatin will be given in 20 mg po qn for 1 month<br>* Other names: atorvastatin calcium;Drug: Dexamethasone<br>* Dexamethasone will be given in 40mg po qd for 4 days<br>|
| Experimental: Dexamethasone<br>The patients will be given dexamethasone 40mg/d for 4 days. | Drug: Dexamethasone<br>* Dexamethasone will be given in 40mg po qd for 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of platelet response | Platelet count will be observed at 1 month, 3 months, 6 months and 12 months after atorvastatin therapy | up to 1 year per subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy associated adverse events | The number and frequency of therapy associated adverse events | up to 1 year per subject | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune Thrombocytopenia