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

NCT06723002 | Not Yet Recruiting Phase 2

• 1 other identifier: ATHEROLIV_ACS
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Coronary Syndrome (ACS); Reactive Hyperemia; Endothelial Dysfunction

Keywords

acute conary syndrome; endothelial dysfunction; olive leaf extract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• MACE rate

  30-day

Study Arms (3)

Arm A

ACTIVE COMPARATOR

Atherolive simple dose

Drug: Atherolive 500mg/day

Arm B

ACTIVE COMPARATOR

Atherolive double dose

Drug: Atherolive 1000/day

Arm C

PLACEBO COMPARATOR

Palcebo

Drug: Placbo_Atherolive

Interventions

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 ).

Arm A

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 ).

Arm B

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 ).

Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

MeSH Terms

Conditions

Acute Coronary Syndrome; Hyperemia

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Semir Nouira, Pr

CONTACT

+21673106046; semir.nouira@gmail.com

khouloud boukhris, PhD Student

CONTACT

kouloud.boukhris@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to one of three groups: Intervention Group 1:Patients in this group will receive the study drug (olive leaf extract) at a dose of 500 mg (two capsules) twice daily, for a total of 1000 mg per day, for one month. Intervention Group 2:Patients in this group will receive the study drug (olive leaf extract) at a dose of 250 mg (one capsule) twice daily, for a total of 500 mg per day, for one month. Control Group:Patients in this group will receive a placebo, with one capsule prescribed twice daily, for one month.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 9, 2024
• Study Start: December 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share