Back to resultsEffect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Pentoxifylline
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Pentoxifylline, Endothelial Dysfunction, Oxidative Stress
Eligibility Criteria
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
Sites / Locations
- Ain Shams University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Control
Arm Description
Pentoxifylline tablets 400mg three times daily for 2 months
Control Group receiving placebo tablets three times daily for 2 months
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Level of Malondialdehyde (MDA) as a marker for oxidative stress
will be measured at baseline and after 2 months
Occurrence of side effects and Major Adverse Cardiac Events (MACE)
recorded rate of occurrence in both groups at the end of the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04367935
Brief Title
Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome
Official Title
Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute Coronary Syndrome, Pentoxifylline, Endothelial Dysfunction, Oxidative Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Pentoxifylline tablets 400mg three times daily for 2 months
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control Group receiving placebo tablets three times daily for 2 months
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Intervention Description
Pentoxifylline tablets 400mg three times daily for 2 months
Primary Outcome Measure Information:
Title
Level of Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1) as a marker for endothelial dysfunction
Description
will be measured at baseline and after 2 months
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Level of Malondialdehyde (MDA) as a marker for oxidative stress
Description
will be measured at baseline and after 2 months
Time Frame
Two months
Title
Occurrence of side effects and Major Adverse Cardiac Events (MACE)
Description
recorded rate of occurrence in both groups at the end of the study
Time Frame
Two Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa Saeed, Bachelor
Organizational Affiliation
Teaching Assistant at the Faculty of Pharmacy, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
11588
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome
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