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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367935
• Other study ID #: PHCL 289
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2021
• Est. completion date: April 25, 2022

Study information

• Verified date: September 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Pentoxifylline
Pentoxifylline tablets 400mg three times daily for 2 months

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Level of Malondialdehyde (MDA) as a marker for oxidative stress	will be measured at baseline and after 2 months	Two months
Secondary	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