Effect of Olive Leaf Extracts on Endothelial Dysfunction in Patients With Acute Coronary Syndrome
NCT ID: NCT06723002
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2024-12-01
2025-12-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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Arm A
Atherolive simple dose
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 ).
Arm B
Atherolive double dose
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 ).
Arm C
Palcebo
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 ).
Interventions
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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 ).
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 ).
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 ).
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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University of Monastir
OTHER
Responsible Party
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Pr. Semir Nouira
Professor
Central Contacts
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Other Identifiers
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ATHEROLIV_ACS
Identifier Type: -
Identifier Source: org_study_id