Clinical trial NCT03692754: Atorvastatin in Management of Newly Diagnosed ITP
Official title: A Single-center Prospective Randomized Study of Atorvastatin in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Immune Thrombocytopenia
Purpura, Thrombocytopenic
Keywords: Immune Thrombocytopenia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. within 3 months from diagnosis,untreated patients, may be male orfemale, between the ages of 18 \~ 80 years.
3. To show a platelet count \> 30×10\^9/L and without bleeding manifestations.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting theplatelet counts within 3 months before the screening visit.
2. Received steroids or other effective therapy for immune thrombocytopenia.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
4. Severe medical condition (lung, hepatic or renal disorder) other than ITP.
5. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
7. 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.
8. Patients who are deemed unsuitable for the study by the investigator.

Primary outcomes:
measure: Evaluation of platelet response
timeFrame: up to 1 year per subject
Secondary outcomes:
measure: Therapy associated adverse events
timeFrame: up to 1 year per subject
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital, Shandong University
state: Shandong
Study officials:
affiliation: Shandong University
name: Ming Hou, Dr
role: PRINCIPAL_INVESTIGATOR
References: