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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05551624

Enrollment

Registered

2022-09-22

Start date

2018-07-04

Completion date

2020-01-23

Last updated

2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immune Thrombocytopenia

Keywords

Immune thrombocytopenia, Atorvastatin, N-acetylcysteine, Steroids

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.

Interventions

DRUGAtorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet

Oral tablets administered daily, atorvastatin once a day and N-acetylcysteine every 8 hours

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention 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

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026