Effect of Genetic Variation on Efficacy and Safety of Lipid-Lowering Drugs

Completed

• Conditions: Acute Coronary Syndromes
• Interventions: Drug: Atorvastatin 40 mg

• Registration Number: NCT07008794
• Lead Sponsor: Assiut University

Brief Summary

The primary end point was to reduce LDL-C levels by at least 50%, while the secondary end point was to achieve an LDL-C level below 55 mg/dL. The incidence and specifics of side effects and laboratory abnormalities were recorded throughout the follow-up period to evaluate safeguarding. Liver function tests were performed at baseline and 12 weeks later. Any muscle-related complaints were noted at baseline and during the 12-week sessions. CK total and Hba1c were also assessed

Detailed Description

CVD are the world's leading cause of death. Egypt has the largest population among the MENA countries, ranks the 2nd in the region for CVD, accounting for 268.11 deaths, or 32.40% of all deaths. Egypt is also ranked 15th globally for cardiovascular mortality.

The total economic costs from non-communicable illnesses in low- and middle-income countries (LMICs) are anticipated to surpass $7 trillion, representing approximately 4% of their annual output. An estimated $25 billion yearly might be saved by a 10% decrease in mortality from IHD greatly paying the expenses of preventative programs The 2019 and 2023 ESC guidelines state that individuals with ACS should aim for a target LDL-C level of \< 55 mg/dL (less than 1.4 mmol/L) and achieve a decrease in LDL-C of at least 50% from the initial level

High-intensity statin regimens are medications that decrease LDL-C concentrations by a minimum of 50% . Some examples of high-intensity regimens include rosuvastatin administered at a dose of 20-40 mg and atorvastatin administered at a dose of 40-80.

Statins have been proven to be safe and well-tolerated in managing ACS. However, high-dose statins occasionally resulted in increased in liver transaminases, particularly ALT, and an elevated frequency of ADR. In addition, the muscular symptoms associated with statin use include clinical rhabdomyolysis and myalgia .

Comparing the effects of high-intensity statins in patients who are globalized after ACS, a topic of numerous investigations recently, rosuvastatin appears to decrease LDL-C levels more effectively than atorvastatin. However, no clinical studies have investigated this issue at Assiut University Heart Hospital. Consequently, this investigation aimed to evaluate the effectiveness and safety of atorvastatin 40 mg and rosuvastatin 20 mg in Egyptian patients who had experienced ACS.

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-11-30
• Study Completion: 2023-03-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients aged exceeding 18 years,
• Those with ACS confirmation, and those who had not started statin medication during the last 2 months were included

Exclusion Criteria

• Patients using bile acid sequestrants (colesevelam, cholestyramine), fenofibrate, ezetimibe, niacin, and/or omega-3, as well as those taking concurrently interacting medications (cyclosporine, gemfibrozil, clarithromycin, and/or itraconazole), were excluded from consideration
• During the recruitment process, the study excluded women who were pregnant, nursing, or of childbearing age without a reliable method of contraception.
• As well as patients with bile duct issues, active liver disease, elevated ALT levels exceeding three times the upper normal limit (UNL), serum creatinine levels above 2 mg/dL,
• Individuals who had undergone or reported a hypersensitivity reaction to any currently used statins

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The first group=atorvastatin on 40 mg/day,	Atorvastatin 40 mg	The first group=atorvastatin on 40 mg/day, the second group = rosuvastatin 20 mg. all groups received standard therapy included dual antiplatelets ,ACEIs, beta blockers.

Primary Outcome Measures

Name	Time	Method
The primary outcome was achieving ≥ 50% LDL-C (mg/dL) reduction from the baseline.	Baseline and 12 weeks	Group 1; administrate atorvastatin 40 mg while the second group administrated rosuvastatin 20 mg.

Secondary Outcome Measures

Name	Time	Method
Target level	Baseline and 12 weeks	To achieve attainment of LDL-C level \< 55 mg/dL from baseline

Trial Locations

Locations (1)

Assiut University Heart Hospital; 🇪🇬 Assiut, Egypt