Clinical trial NCT07008794: Effect of Genetic Variation on Efficacy and Safety of Lipid-Lowering Drugs
Official title: Studying the Effect of Genetic Variation on Efficacy and Safety of Lipid-Lowering Drugs in Patients With Cardiovascular Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndromes
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Initially, the study collected patient information, including smoking status, age, BMI, and sex. Furthermore, concurrent medication use, comorbidities, and a detailed medical history were collected.

Standard laboratory tests included baseline measurements of HbA1c, blood urea nitrogen, serum creatinine, and whole blood picture. While the following parameters at baseline and after 12 weeks were evaluated: CK, HBA1c, TG, HDL, VLDL-C, and LDL-C. Liver function tests included AST and ALT levels.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome was achieving ≥ 50% LDL-C (mg/dL) reduction from the baseline.
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Target level
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Heart Hospital
Study officials:
affiliation: Assiut University
name: Hosam Ali Mohamed, Professor
role: STUDY_DIRECTOR
References:
citation: WHO. Global causes of deaths. 2021.
citation: Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J Acute Cardiovasc Care. 2024 Feb 9;13(1):55-161. doi: 10.1093/ehjacc/zuad107. No abstract available.
citation: Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.