Atorvastatin in Management of Newly Diagnosed ITP

NCT ID: NCT03692754

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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

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Immune Thrombocytopenia Purpura, Thrombocytopenic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AT with 10 mg/d

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

Group Type ACTIVE_COMPARATOR

Atorvastatin 10mg

Intervention Type DRUG

Atorvastatin will be given in 10 mg po qn for 1 month

Dexamethasone

Intervention Type DRUG

Dexamethasone will be given in 40mg po qd for 4 days

AT with 20 mg/d

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

Group Type ACTIVE_COMPARATOR

Atorvastatin 20mg

Intervention Type DRUG

Atorvastatin will be given in 20 mg po qn for 1 month

Dexamethasone

Intervention Type DRUG

Dexamethasone will be given in 40mg po qd for 4 days

Dexamethasone

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone will be given in 40mg po qd for 4 days

Interventions

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Atorvastatin 20mg

Atorvastatin will be given in 20 mg po qn for 1 month

Intervention Type DRUG

Atorvastatin 10mg

Atorvastatin will be given in 10 mg po qn for 1 month

Intervention Type DRUG

Dexamethasone

Dexamethasone will be given in 40mg po qd for 4 days

Intervention Type DRUG

Other Intervention Names

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atorvastatin calcium atorvastatin calcium

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Ming Hou

Professor and Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ming Hou, Dr

Role: PRINCIPAL_INVESTIGATOR

Shandong University

Locations

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Qilu hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Ming Hou, Dr

Role: CONTACT

+86-531-82169114 ext. 9879

Facility Contacts

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Ming Hou

Role: primary

Other Identifiers

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Atorvastatin in ITP

Identifier Type: -

Identifier Source: org_study_id

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