Effect of Olive Leaf Extracts on Endothelial Dysfunction in Patients With Acute Coronary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atherolive 500mg/day, Atherolive 1000/day, Placbo_Atherolive.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndrome (ACS), Reactive Hyperemia, Endothelial Dysfunction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Olive Leaf Extracts on Endothelial Dysfunction and Short-term Outcome in Patients With Acute Coronary Syndrome
Overview
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.
Interventions
- Drug Atherolive 500mg/day
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 ). - Drug Atherolive 1000/day
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 ). - Drug Placbo_Atherolive
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 ).
Primary outcome measures
- Reactive Hyperemia Index (RHI) [Time frame: 30-day]
Secondary outcome measures (1)
- MACE rate [Time frame: 30-day]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06723002 · ATHEROLIV_ACS