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

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

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).

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Pentoxifylline

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11588
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention; Pentoxifylline tablets 400mg three times daily for 2 months	Drug: Pentoxifylline; Pentoxifylline tablets 400mg three times daily for 2 months
NO_INTERVENTION: Control; Control Group receiving placebo tablets three times daily for 2 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Asmaa Saeed, Bachelor, Teaching Assistant at the Faculty of Pharmacy, Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): April 25, 2022
• Study Completion (ACTUAL): April 25, 2022

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: April 26, 2020
• First Posted (ACTUAL): April 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Oxidative Stress; Acute Coronary Syndrome; Pentoxifylline; Endothelial Dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Pentoxifylline
• Other Study ID Numbers: PHCL 289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No