Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome

Ain Shams University43 enrolled

Overview

This study aims to investigate the effect of pentoxifylline administration on the status of endothelial function and oxidative stress biomarkers in patients with Acute Coronary Syndrome (ACS).

The study will be carried out at Ain Shams University Hospitals. Patients with ACS who meet the eligibility criteria and consent to participate in the study will be randomly allocated to either the intervention group or the control group. All participants will receive the standard pharmacologic treatment for ACS according to the applied guidelines offered by the facility. In addition, patients in the intervention group will receive Pentoxifylline tablets 400mg orally three times daily. Patient follow-up will be scheduled every 2 weeks for each patient to check the tolerability, the development of side effects, any medication change and medication adherence. Physical examination at each visit will be done by physician in attendance for all patients in both groups. A blood sample will be taken at baseline and at the end of the study after 2 months. for measurement of basic laboratory parameters (Complete Blood Count, Liver Function Tests, Kidney Function Tests ,..etc), the level of Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1) as a marker for endothelial dysfunction, the level of Malondialdehyde (MDA) as a marker for oxidative stress.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Coronary Syndrome

Interventions

PentoxifyllineDRUG

Pentoxifylline tablets 400mg three times daily for 2 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18-80 years old. * Recent ACS diagnosed-patients within the past 2 weeks. Exclusion Criteria: * Known allergy to pentoxifylline * Heart failure New York Heart Association (NYHA) class III or IV * Severe Left Ventricular Dysfunction (left ventricular ejection fraction \<30%) * High Serum creatinine level ≥ 2 mg/dl * Liver disease (baseline alanine transaminase \>2.5 times the upper limit of normal) * Active bleeding or bleeding diathesis * Major surgery or trauma within 1 month * Recent cerebral and/or retinal hemorrhage within 3 months

Locations (1)

Ain Shams University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

Level of Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1) as a marker for endothelial dysfunction

will be measured at baseline and after 2 months

Time frame: Two months

Secondary Outcomes

Level of Malondialdehyde (MDA) as a marker for oxidative stress

will be measured at baseline and after 2 months

Time frame: Two months

Occurrence of side effects and Major Adverse Cardiac Events (MACE)

recorded rate of occurrence in both groups at the end of the study

Time frame: Two Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.