NCT03692754

Atorvastatin in Management of Newly Diagnosed ITP

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic

Interventions

Type	Name	Description
DRUG	Atorvastatin 20mg	Atorvastatin will be given in 20 mg po qn for 1 month
DRUG	Atorvastatin 10mg	Atorvastatin will be given in 10 mg po qn for 1 month
DRUG	Dexamethasone	Dexamethasone will be given in 40mg po qd for 4 days

Timeline

• Start date: 2021-11-01
• Primary completion: 2021-12-01
• Completion: 2023-12-01
• First posted: 2018-10-02
• Last updated: 2021-09-05

Locations

1 site across 1 country: China