Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome
1 other identifier
interventional
43
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2022
CompletedSeptember 7, 2022
September 1, 2022
1.3 years
April 26, 2020
September 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Level of Malondialdehyde (MDA) as a marker for oxidative stress
Two months
Occurrence of side effects and Major Adverse Cardiac Events (MACE)
Two Months
Study Arms (2)
Intervention
ACTIVE COMPARATORPentoxifylline tablets 400mg three times daily for 2 months
Control
NO INTERVENTIONControl Group receiving placebo tablets three times daily for 2 months
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged 18-80 years old.
- Recent ACS diagnosed-patients within the past 2 weeks.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University Hospitals
Cairo, 11588, Egypt
Related Publications (1)
Saeed A, Farouk MM, Sabri NA, Saleh MA, Ahmed MA. Effect of pentoxifylline on endothelial dysfunction, oxidative stress and inflammatory markers in STEMI patients. Future Sci OA. 2024 May 15;10(1):FSO967. doi: 10.2144/fsoa-2023-0266. eCollection 2024.
PMID: 38817362DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asmaa Saeed, Bachelor
Teaching Assistant at the Faculty of Pharmacy, Ain Shams University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching Assistant
Study Record Dates
First Submitted
April 26, 2020
First Posted
April 29, 2020
Study Start
January 1, 2021
Primary Completion
April 25, 2022
Study Completion
April 25, 2022
Last Updated
September 7, 2022
Record last verified: 2022-09