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

Early Phase 1

Completed

• Conditions: Primary Immune Thrombocytopenia
• Interventions: Drug: Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet

• Registration Number: NCT05551624
• Lead Sponsor: Hospital Civil de Guadalajara

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-07-04
• Primary Completion: 2019-12-11
• Study Completion: 2020-01-23
• Status Verified: 2022-09
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-20
• Last Update Submitted: 2022-09-20
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atorvastatin + N-acetylcysteine	Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet	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)

Primary Outcome Measures

Name	Time	Method
Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months	Baseline and 1, 3, 6, and 12 months after intervention	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.

Trial Locations

Locations (1)

Hospital Civil de Guadalajara Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico