Atorvastatin in Management of Newly Diagnosed ITP

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Ming Hou，Shandong University

Tracking Information

First Submitted Date ^ICMJE

September 29, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

June 1, 2018

Estimated Primary Completion Date

December 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluation of platelet response[ Time Frame: up to 1 year per subject ]

Platelet count will be observed at 1 month, 3 months, 6 months and 12 months after atorvastatin therapy

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Therapy associated adverse events[ Time Frame: up to 1 year per subject ]
The number and frequency of therapy associated adverse events

Descriptive Information

Brief Title ^ICMJE

Atorvastatin in Management of Newly Diagnosed ITP

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Atorvastatin 20mg
Atorvastatin will be given in 20 mg po qn for 1 year
Drug: Atorvastatin 10mg
Atorvastatin will be given in 10 mg po qn for 1 year

Study Arms

Active Comparator: AT with 10 mg/d
The patients will be given receive atorvastatin in 10 mg/d
Active Comparator: AT with 20 mg/d
The patients will be given receive atorvastatin in 20 mg/d

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 1, 2020

Estimated Primary Completion Date

December 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - 1. Meet the diagnostic criteria for immune thrombocytopenia. 2. within 3 months from diagnosis,untreated patients, may be male or female, 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 the platelet 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. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 6. 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. 7. Patients who are deemed unsuitable for the study by the investigator.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Ming Hou，Shandong University

Study Sponsor ^ICMJE

Shandong University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Ming Hou, Dr Shandong University

PRS Account

Shandong University

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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