Effect of Olive Leaf Extracts on Endothelial Dysfunction in Patients With Acute Coronary Syndrome (ACS_ATHEROLIV)

University of Monastir

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Endothelial Dysfunction; Reactive Hyperemia; Acute Coronary Syndrome (ACS)

Treatments: Drug: Atherolive 500mg/day; Drug: Atherolive 1000/day; Drug: Placbo_Atherolive

Study type: Interventional

Funder types: Other

Identifiers

NCT06723002

ATHEROLIV_ACS

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

Arm A

Active Comparator group

Description:

Atherolive simple dose

Treatment:

Drug: Atherolive 500mg/day

Arm B

Active Comparator group

Description:

Atherolive double dose

Treatment:

Drug: Atherolive 1000/day

Arm C

Placebo Comparator group

Description:

Palcebo

Treatment:

Drug: Placbo_Atherolive