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NCT Number: NCT04367935

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

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Hospitals

Cairo, 11588, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pentoxifylline

Drug

Pentoxifylline tablets 400mg three times daily for 2 months

Primary outcomes

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

    Time frame: Two months

    will be measured at baseline and after 2 months

Secondary outcomes

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

    Time frame: Two months

    will be measured at baseline and after 2 months

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

    Time frame: Two Months

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2020
Registry last updated
Sep 7, 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.

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