Atorvastatin in Management of Newly Diagnosed ITP

Phase 2

• Conditions: Immune Thrombocytopenia; Purpura, Thrombocytopenic
• Interventions: Drug: Atorvastatin 10mg; Drug: Atorvastatin 20mg; Drug: Dexamethasone

• Registration Number: NCT03692754
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study First Submitted: 2018-09-29
• Study First Submitted QC: 2018-09-29
• Study First Posted: 2018-10-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-05
• Study Start: 2021-11-01
• Primary Completion: 2021-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AT with 10 mg/d	Atorvastatin 10mg	The patients will be given receive atorvastatin in 10 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.
AT with 20 mg/d	Atorvastatin 20mg	The patients will be given atorvastatin in 20 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.
AT with 10 mg/d	Dexamethasone	The patients will be given receive atorvastatin in 10 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.
AT with 20 mg/d	Dexamethasone	The patients will be given atorvastatin in 20 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.
Dexamethasone	Dexamethasone	The patients will be given dexamethasone 40mg/d for 4 days.

Primary Outcome Measures

Name	Time	Method
Evaluation of platelet response	up to 1 year per subject	Platelet count will be observed at 1 month, 3 months, 6 months and 12 months after atorvastatin therapy

Secondary Outcome Measures

Name	Time	Method
Therapy associated adverse events	up to 1 year per subject	The number and frequency of therapy associated adverse events

Trial Locations

Locations (1)

Qilu hospital, Shandong University; 🇨🇳 Jinan, Shandong, China