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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Pentoxifylline tablets 400mg three times daily for 2 months |
|
| Control | No Intervention | Control Group receiving placebo tablets three times daily for 2 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline | Drug | Pentoxifylline tablets 400mg three times daily for 2 months |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asmaa Saeed, Bachelor | Teaching Assistant at the Faculty of Pharmacy, Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | 11588 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38817362 | Derived | 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. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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recorded rate of occurrence in both groups at the end of the study
| Two Months |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |