Acute Coronary Syndrome (ACS)Phase 2/3ACS_ATHEROLIVNCT06723002
Effect of Olive Leaf Extracts on Endothelial Dysfunction in Patients With Acute Coronary Syndrome
A Phase 2/3 study testing Atherolive 500mg/day, Atherolive 1000/day and Placbo_Atherolive in people with Acute Coronary Syndrome (ACS) and Reactive Hyperemia, run by University of Monastir.
Trial summary
the study aims to examine the short-term (30 days) effects of olive leaf extract on endothelial function in patients with acute coronary syndrome (ACS). This investigation will be conducted on patients admitted to the emergency department for ACS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome (ACS), Reactive Hyperemia, Endothelial Dysfunction
- What is being tested?
- Atherolive 500mg/day, Atherolive 1000/day and Placbo_Atherolive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 30 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years. Patients presenting with ST-segment alterations at rest, including ST elevation, with or without troponin elevation.
- Patients who have not undergone surgery or have no additional primary percutaneous coronary intervention (P-PCI) planned within 8 weeks from the initial P-PCI.
- Patients who provide informed consent. Patients available for and willing to adhere to follow-up procedures. Patients without significant cognitive impairment. Patients with a life expectancy of at least 2 years.
Who cannot join
- Severe LV hypertrophy (>15 mm);
- Patients with any evidence of inflammatory or malignant disease.
- Patient having valvular heart disease, pacemaker; cardiogenic shock
- Patient having any serious non-cardiac disease associated with a life expectancy <1 year
- Patients undergoing surgery within 30 days
- Patient having gastrointestinal disorder such as Crohn's disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
khouloud boukhris, PhD Student contact
About this study
Official title: Effect of Olive Leaf Extracts on Endothelial Dysfunction and Short-term Outcome in Patients With Acute Coronary Syndrome
the study aims to examine the short-term (30 days) effects of olive leaf extract on endothelial function in patients with acute coronary syndrome (ACS).
This investigation will be conducted on patients admitted to the emergency department for ACS. All participants will be screened and included within 24 hours post-ACS event and prior to discharge from the emergency department.
- Being tested
- Atherolive 500mg/day, Atherolive 1000/day, Placbo_Atherolive
- Keywords
- acute conary syndrome, endothelial dysfunction, olive leaf extract
- Medical subject headings
- Acute Coronary Syndrome, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atherolive 500mg/dayDrug
Patients will receive a study drug (olive leaf extracts) which will be prescribed at dose of 250 mg (one capsule ) twice daily ( total500mg daily) for one month.
patients will be assigned to one of three arm using a computer-generated randomization list ( 1:1:1 allocation ).
Atherolive 1000/dayDrug
Patients will receive a study drug (olive leaf extracts) which will be prescribed at dose of 500 mg (two capsule ) twice daily ( total 1000mg daily) for one month.
patients will be assigned to one of three arm using a computer-generated randomization list ( 1:1:1 allocation ).
Placbo_AtheroliveDrug
Patients will receive placebo which will be prescribed one capsule twice daily for one months.
patients will be assigned to one of three arm using a computer-generated randomization list ( 1:1:1 allocation ).
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Atherolive simple dose Receives: Drug: Atherolive 500mg/day |
| Arm B | Active comparator | Atherolive double dose Receives: Drug: Atherolive 1000/day |
| Arm C | Placebo comparator | Palcebo Receives: Drug: Placbo_Atherolive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive Hyperemia Index (RHI)
Change in endothelial function will be evaluated using Reactive Hyperemia Index (RHI) via Peripheral Arterial Tonometry (PAT), measured at baseline and after drug administration (olive leaf extract) in patients with acute coronary syndrome.
Measured: 30-day
Secondary outcomes (1)
MACE rate
-The MACE (Major Adverse Cardiovascular Events) rate will include the following components: Myocardial infarction readmission Nonfatal stroke readmission Cardiovascular death Coronary revascularization, including percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) Admission for heart failure
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned to one of three groups: Intervention Group 1:Patients in this group will receive the study drug (olive leaf extract) at a dose of 500 mg (two capsules) twice daily, for a total of 1000 mg per day, for one month. Intervention Group 2:Patients in this group will receive the study drug (olive leaf extract) at a dose of 250 mg (one capsule) twice daily, for a total of 500 mg per day, for one month. Control Group:Patients in this group will receive a placebo, with one capsule prescribed twice daily, for one month.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723002
- Sponsor's protocol ID
- ATHEROLIV_ACS
- Acronym
- ACS_ATHEROLIV
- Status last verified
- Dec 2024
- First submitted
- 20 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Olive Leaf Extracts on Endothelial Dysfunction and Short-term Outcome in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06723002
- Acronym / sponsor ID
- ACS_ATHEROLIV / ATHEROLIV_ACS
- Keywords
- acute conary syndrome, endothelial dysfunction, olive leaf extract
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Dec 2024 (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.
the study aims to examine the short-term (30 days) effects of olive leaf extract on endothelial function in patients with acute coronary syndrome (ACS).
This investigation will be conducted on patients admitted to the emergency department for ACS. All participants will be screened and included within 24 hours post-ACS event and prior to discharge from the emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three groups: Intervention Group 1:Patients in this group will receive the study drug (olive leaf extract) at a dose of 500 mg (two capsules) twice daily, for a total of 1000 mg per day, for one month. Intervention Group 2:Patients in this group will receive the study drug (olive leaf extract) at a dose of 250 mg (one capsule) twice daily, for a total of 500 mg per day, for one month. Control Group:Patients in this group will receive a placebo, with one capsule prescribed twice daily, for one month.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Atherolive 500mg/dayAtherolive simple dose |
| Arm B | Active comparator | Drug: Atherolive 1000/dayAtherolive double dose |
| Arm C | Placebo comparator | Drug: Placbo_AtherolivePalcebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years. Patients presenting with ST-segment alterations at rest, including ST elevation, with or without troponin elevation.
- Patients who have not undergone surgery or have no additional primary percutaneous coronary intervention (P-PCI) planned within 8 weeks from the initial P-PCI.
- Patients who provide informed consent. Patients available for and willing to adhere to follow-up procedures. Patients without significant cognitive impairment. Patients with a life expectancy of at least 2 years.
Key exclusion criteria (6 listed)
- Severe LV hypertrophy (>15 mm);
- Patients with any evidence of inflammatory or malignant disease.
- Patient having valvular heart disease, pacemaker; cardiogenic shock
- Patient having any serious non-cardiac disease associated with a life expectancy <1 year
- Patients undergoing surgery within 30 days
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 |
|---|---|---|
| Atherolive 500mg/dayPatients will receive a study drug (olive leaf extracts) which will be prescribed at dose of 250 mg (one capsule ) twice daily ( total500mg daily) for one month. patients will be assigned to one of three arm using a computer-generated randomization list ( 1:1:1 allocation ). | Drug | Arm A |
| Atherolive 1000/dayPatients will receive a study drug (olive leaf extracts) which will be prescribed at dose of 500 mg (two capsule ) twice daily ( total 1000mg daily) for one month. patients will be assigned to one of three arm using a computer-generated randomization list ( 1:1:1 allocation ). | Drug | Arm B |
| Placbo_AtherolivePatients will receive placebo which will be prescribed one capsule twice daily for one months. patients will be assigned to one of three arm using a computer-generated randomization list ( 1:1:1 allocation ). | Drug | Arm C |
Primary outcome
Reactive Hyperemia Index (RHI)
Time frame: 30-day
Change in endothelial function will be evaluated using Reactive Hyperemia Index (RHI) via Peripheral Arterial Tonometry (PAT), measured at baseline and after drug administration (olive leaf extract) in patients with acute coronary syndrome.
1 secondary outcome
MACE rate
Time frame: 30-day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Acute Coronary Syndrome (ACS)
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
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.
khouloud boukhris, PhD Student contact
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atherolive 500mg/day, Atherolive 1000/day and Placbo_Atherolive in people with Acute Coronary Syndrome (ACS) and Reactive Hyperemia, run by University of Monastir.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Semir Nouira, Pr (+21673106046, semir.nouira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactive Hyperemia Index (RHI) (time frame: 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2024.