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

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.

Completed

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Key information

Conditions

Primary Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Sep 22, 2022
Registry last updated: Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed