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

ConditionsAcute Coronary Syndrome (ACS)Reactive Hyperemia Endothelial Dysfunction

Trial statusNot yet recruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Monastir

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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 ).

Treatment groups

300 Participants

are divided into 3 treatment groups

Group A: Arm AActive comparator 1 intervention

Group B: Arm BActive comparator 1 intervention

Group C: Arm CPlacebo comparator 1 intervention

Trial 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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Monastir

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: