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

Phase 2

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Pentoxifylline

• Registration Number: NCT04367935
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-04-26
• Study First Posted: 2020-04-29
• Study Start: 2021-01-01
• Primary Completion: 2022-04-25
• Study Completion: 2022-04-25
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Pentoxifylline	Pentoxifylline tablets 400mg three times daily for 2 months

Primary Outcome Measures

Name	Time	Method
Level of Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1) as a marker for endothelial dysfunction	Two months	will be measured at baseline and after 2 months

Secondary Outcome Measures

Name	Time	Method
Occurrence of side effects and Major Adverse Cardiac Events (MACE)	Two Months	recorded rate of occurrence in both groups at the end of the study
Level of Malondialdehyde (MDA) as a marker for oxidative stress	Two months	will be measured at baseline and after 2 months

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt