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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 11, 2019

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

  • Drug: 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

Arms, Groups and Cohorts

  • Experimental: 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)

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Civil de Guadalajara
  • Provider of Information About this Clinical Study
    • Principal Investigator: Enrique Cervantes-Perez, Attending Internal Medicine Physician and Professor to the Department of Internal Medicine, Hospital Civil de Guadalajara “Fray Antonio Alcalde”. – Hospital Civil de Guadalajara
  • Overall Official(s)
    • Enrique Cervantes-Perez, MD, MSc, Principal Investigator, Hospital Civil de Guadalajara

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