Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine

Study Overview
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Brief Summary
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The purpose of this study is to assess the ability of Atorvastatin and N-acetyl cysteine to elevate the blood (serum) platelet count in patients with Immune Thrombocytopenia as a mean of a new treatment.

Detailed Description
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Evaluate the efficacy in the elevation of platelet count of the combination of atorvastatin and N-acetyl cysteine in patients with immune thrombocytopenia resistant to steroid therapy or with relapse after treatment, a prospective, proof of concept clinical trial.

Official Title
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Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine in Patients With Primary Immune Thrombocytopenia Resistant to Steroid Treatment or in Relapse: An Exploratory Clinical Trial

Conditions
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Primary Immune Thrombocytopenia

Intervention / Treatment
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* Drug: Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that give their informed consent before the procedures of study Thrombocytopenia before intervention (<100 x10^9 /L) Patients of either biological sex older than 15 years old Patients with previous diagnosis of primary immune thrombocytopenia that not reach complete remission after treatment (steroid based) or that have a relapse If the patient is taking steroid based treatment, the dose need to be stable before intervention. Exclusion Criteria: Patients with secondary immune thrombocytopenia Pregnant patients Patients with hypersensitivity to study treatments Patients that are taking anticoagulant medication or any drug that have an effect on platelet count Hepatic alteration consisting in serum levels of Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 times above superior laboratory reference limit. Elevation of serum levels of Creatinine or bilirubins above 1.5 mg/dl Any cancer diagnosis Coronary heart disease, congestive heart failure, uncontrolled hypertension or arrhythmias. Previous autoimmune disease diagnosis including: systemic lupus erythematosus, rheumatoid arthritis or systemic sclerosis.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single group, exploratory (proof of concept) clinical trial to evaluate the effect in serum platelet count of Atorvastatin plus N-acetylcysteine in patients with primary immune thrombocytopenia resistent to steroid therapy or in relapse
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin + N-acetylcysteine<br>Patients included in the study received an oral treatment of Atorvastatin 40 mg daily and N-acetylcysteine 400 mg every 8 hours, for at least 1 month (up to 12 months) | Drug: Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet<br>* Oral tablets administered daily, atorvastatin once a day and N-acetylcysteine every 8 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months | Blood samples of all participants will be taken previous to the intervention of study and in the 1, 3, 6, adn 12 month, this with the objective of evaluate changes in platelet count after intervention expecting to elevate the platelet count. | Baseline and 1, 3, 6, and 12 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune thrombocytopenia, Atorvastatin, N-acetylcysteine, Steroids