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

NCT ID: NCT05551624

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-04
• Study Completion Date: 2020-01-23

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.

Conditions

Primary Immune Thrombocytopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atorvastatin + N-acetylcysteine

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)

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Civil de Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Enrique Cervantes-Perez

Attending Internal Medicine Physician and Professor to the Department of Internal Medicine, Hospital Civil de Guadalajara "Fray Antonio Alcalde".

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrique Cervantes-Perez, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hospital Civil de Guadalajara

Locations

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

178/19

Identifier Type: -

Identifier Source: org_study_id