Investigating the effectiveness of combination therapy of timibe with statins on the treatment of patients with acute coronary syndrome

Comparison of the effectiveness of combination therapy of eztimibe with Statins versus high-dose rosuvastatin and atorvastatin in reducing lipid Factors, CRP, and liver enzymes in acute coronary syndrome patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250528065945N1

Enrollment

264

Registered

2025-10-13

Start date

2025-10-22

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome (ACS). Acute ischemic heart disease, unspecified

Interventions

Intervention 1: Intervention Group 1: Atorvastatin medication (80 mg daily dose), manufactured by Actover Pharmaceutical Company

administration: oral tablet

duration of treatment: 12 weeks. Intervention 2: Intervention Group 2: Rosuvastatin (40 mg daily dose), manufactured by Actover Pharmaceutical Company

duration of treatment: 12 weeks. Intervention 3: Intervention Group 3: Ezetimibe (10 mg daily dose), manufactured by Abidi Pharmaceutical Company, together with Rosuvastatin (40 mg daily dose), manufa

administration: oral tablets

duration of treatment: 12 weeks. Intervention 4: Intervention Group 4: Ezetimibe (10 mg daily dose), manufactured by Abidi Pharmaceutical Company, combined with Atorvastatin (80 mg daily dose), manufa

duration of treatment: 12 weeks.

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: Written informed consent before participating in the clinical trial Age over 20 years Have coronary artery disease with a clinical diagnosis including ischemic heart disease and acute coronary syndrome (unstable angina and acute myocardial infarction) Patients with LDL-C levels above 130 mg/dL and requiring treatment with statin drugs

Exclusion criteria

Exclusion criteria: LFT more than 3 times the normal range Recipient of any dose of rosuvastatin and atorvastatin prior to study entry Taking ezetimibe, niacin, or fibrates in the past 3 months Recipient of rifampicin, ketoconazole Allergy to or intolerance to statins Severe liver complications Cardiogenic shock patients and patients with creatinine clearance <30 mL/min or creatine phosphokinase or aspartate Febrile infectious, autoimmune, and inflammatory diseases Patients with cancer

Design outcomes

Primary

Measure	Time frame
Total cholesterol. Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: Biochemistry.;Triglyceride. Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: Biochemistry.;Low-density lipoprotein cholesterol. Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: Biochemistry.;High-density lipoprotein cholesterol. Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: Biochemistry.;High-sensitivity C-reactive protein. Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: Biochemistry.	—

Measure

Time frame

Total cholesterol. Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: Biochemistry.;Triglyceride. Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: Biochemistry.;Low-density lipoprotein cholesterol. Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: Biochemistry.;High-density lipoprotein cholesterol. Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: Biochemistry.;High-sensitivity C-reactive protein. Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: Biochemistry.

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Secondary

Measure	Time frame
Alanine aminotransferase (ALT). Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: By enzymatic and calorimetric methods.;Aspartate aminotransferase (AST). Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: By enzymatic and calorimetric methods.;Creatine phosphokinase (CPK). Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: By enzymatic method.	—

Measure

Time frame

Alanine aminotransferase (ALT). Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: By enzymatic and calorimetric methods.;Aspartate aminotransferase (AST). Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: By enzymatic and calorimetric methods.;Creatine phosphokinase (CPK). Timepoint: At the beginning of the study (before the intervention) and 12 weeks thereafter. Method of measurement: By enzymatic method.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Nasrolahi

Shahre-kord University of Medical Sciences

Maryamnasrolahi@gmail.com+98 38 3110 7000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026