Acute Coronary SyndromePhase 2/3NCT04367935
Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome
A Phase 2/3 study testing Pentoxifylline in people with Acute Coronary Syndrome, run by Ain Shams University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 25 Apr 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years old.
- Recent ACS diagnosed-patients within the past 2 weeks.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome: A Pilot Study
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).
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Pentoxifylline
- Keywords
- Acute Coronary Syndrome, Pentoxifylline, Endothelial Dysfunction, Oxidative Stress
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Pentoxifylline tablets 400mg three times daily for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Pentoxifylline tablets 400mg three times daily for 2 months Receives: Drug: Pentoxifylline |
| Control | No intervention | Control Group receiving placebo tablets three times daily for 2 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two months
Secondary outcomes (2)
Level of Malondialdehyde (MDA) as a marker for oxidative stress
will be measured at baseline and after 2 months
Measured: Two months
Occurrence of side effects and Major Adverse Cardiac Events (MACE)
recorded rate of occurrence in both groups at the end of the study
Measured: Two Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Jan 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Saeed Mohamed Monir, Ain Shams University
- Investigators
- Asmaa Saeed, Bachelor, Principal investigator, Teaching Assistant at the Faculty of Pharmacy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367935
- Sponsor's protocol ID
- PHCL 289
- Status last verified
- Sep 2022
- First submitted
- 26 Apr 2020
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38817362
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT04367935
- Acronym / sponsor ID
- PHCL 289
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Pentoxifylline, Endothelial Dysfunction, Oxidative Stress
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: PentoxifyllinePentoxifylline tablets 400mg three times daily for 2 months |
| Control | No intervention | –Control Group receiving placebo tablets three times daily for 2 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-80 years old.
- Recent ACS diagnosed-patients within the past 2 weeks.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PentoxifyllinePentoxifylline tablets 400mg three times daily for 2 months | Drug | Intervention |
Primary outcome
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
2 secondary outcomes
Level of Malondialdehyde (MDA) as a marker for oxidative stress
Time frame: Two months
Occurrence of side effects and Major Adverse Cardiac Events (MACE)
Time frame: Two Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Derived from this study: PubMed 38817362Saeed 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa Saeed, Bachelor principal investigator
Teaching Assistant at the Faculty of Pharmacy, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pentoxifylline in people with Acute Coronary Syndrome, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1) as a marker for endothelial dysfunction (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04367935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.