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NCT Number: NCT06723002

Effect of Olive Leaf Extracts on Endothelial Dysfunction 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.

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Key information

Conditions

Acute Coronary Syndrome (ACS) Acute Coronary Syndrome Cardiovascular Diseases Endothelial Dysfunction Heart Diseases Hyperemia Myocardial Ischemia Reactive Hyperemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atherolive 500mg/day

Drug

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/day

Drug

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_Atherolive

Drug

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 ).

Primary outcomes

  1. Reactive Hyperemia Index (RHI)

    Time frame: 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 outcomes

  1. MACE rate

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Semir Nouira, Pr

CONTACT

[email protected]

+21673106046

khouloud boukhris, PhD Student

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

Effect of Olive Leaf Extracts on Endothelial Dysfunction and Short-term Outcome in Patients With Acute Coronary Syndrome

Acronym: ACS_ATHEROLIV

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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