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

Hospital Civil de Guadalajara

Status and phase: Completed; Early Phase 1

Conditions: Primary Immune Thrombocytopenia

Treatments: Drug: Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05551624

178/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Atorvastatin + N-acetylcysteine

Experimental group

Description:

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)

Treatment:

Drug: Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet