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

Phase 3Not Yet RecruitingNCT06723002

University of Monastir300 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Acute Coronary Syndrome (ACS)Reactive Hyperemia Endothelial Dysfunction

Interventions

Atherolive 500mg/dayDRUG

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 ).

Atherolive 1000/dayDRUG

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 ).

Placbo_AtheroliveDRUG

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 ).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 30-day

Secondary Outcomes

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

Time frame: 30-day

Central Contacts

Semir Nouira, Pr

CONTACT

+21673106046 semir.nouira@gmail.com

khouloud boukhris, PhD Student

CONTACT

kouloud.boukhris@gmail.com

Data from ClinicalTrials.gov

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