Atorvastatin in Management of Newly Diagnosed ITP

Shandong University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Immune Thrombocytopenia; Purpura, Thrombocytopenic

Treatments: Drug: Atorvastatin 10mg; Drug: Dexamethasone; Drug: Atorvastatin 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03692754

Atorvastatin in ITP

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

AT with 10 mg/d

Active Comparator group

Description:

The patients will be given receive atorvastatin in 10 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.

Treatment:

Drug: Dexamethasone

Drug: Atorvastatin 10mg

AT with 20 mg/d

Active Comparator group

Description:

The patients will be given atorvastatin in 20 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.

Treatment:

Drug: Atorvastatin 20mg

Drug: Dexamethasone

Dexamethasone

Experimental group

Description:

The patients will be given dexamethasone 40mg/d for 4 days.

Treatment:

Drug: Dexamethasone