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

Last updated: December 3, 2024
Sponsor: University of Monastir
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Heart Attack (Myocardial Infarction)

Heart Disease

Atherosclerosis

Treatment

Atherolive 500mg/day

Atherolive 1000/day

Placbo_Atherolive

Clinical Study ID

NCT06723002
ATHEROLIV_ACS
  • Ages > 18
  • All Genders

Study 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. All participants will be screened and included within 24 hours post-ACS event and prior to discharge from the emergency department.

Eligibility Criteria

Inclusion

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

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 <1year

  • Patients undergoing surgery within 30 days

  • Patient having gastrointestinal disorder such as Crohn's disease

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Atherolive 500mg/day
Phase: 2/3
Study Start date:
December 01, 2024
Estimated Completion Date:
December 30, 2025