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

Phase 2

Not yet recruiting

• Conditions: Acute Coronary Syndrome (ACS); Reactive Hyperemia; Endothelial Dysfunction
• Interventions: Drug: Placbo_Atherolive; Drug: Atherolive 500mg/day; Drug: Atherolive 1000/day

• Registration Number: NCT06723002
• Lead Sponsor: University of Monastir

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-20
• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm C	Placbo_Atherolive	Palcebo
Arm A	Atherolive 500mg/day	Atherolive simple dose
Arm B	Atherolive 1000/day	Atherolive double dose

Primary Outcome Measures

Name	Time	Method
Reactive Hyperemia Index (RHI)	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.

Secondary Outcome Measures

Name	Time	Method
MACE rate	30-day	-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