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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome: A Pilot Study

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Pentoxifylline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Pentoxifylline tablets 400mg three times daily for 2 months | Drug: Pentoxifylline<br>* Pentoxifylline tablets 400mg three times daily for 2 months<br>|
| No Intervention: Control<br>Control Group receiving placebo tablets three times daily for 2 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Malondialdehyde (MDA) as a marker for oxidative stress | will be measured at baseline and after 2 months | 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 | Two Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Pentoxifylline, Endothelial Dysfunction, Oxidative Stress