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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endothelial Dysfunction; Acute Coronary Syndrome (ACS); Reactive Hyperemia
• Intervention / Treatment: Drug: Atherolive 500mg/day; Drug: Atherolive 1000/day; Drug: Placbo_Atherolive

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Semir Nouira, Pr; Phone Number: +21673106046; Email: semir.nouira@gmail.com
• Study Contact Backup: Name: khouloud boukhris, PhD Student; Email: kouloud.boukhris@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A; Atherolive simple dose	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 ).
Active Comparator: Arm B; Atherolive double dose	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 ).
Placebo Comparator: Arm C; Palcebo	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 ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30-day

Collaborators and Investigators

• Sponsor: University of Monastir

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: endothelial dysfunction; olive leaf extract; acute conary syndrome
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease; Myocardial Ischemia; Syndrome; Acute Coronary Syndrome; Hyperemia
• Other Study ID Numbers: ATHEROLIV_ACS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes