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

NCT07008794 | Completed FDA Drug

• 1 other identifier: Statin in cardiovascular
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Coronary Syndromes

Outcome Measures

Primary Outcomes (1)

• The primary outcome was achieving ≥ 50% LDL-C (mg/dL) reduction from the baseline.

  Group 1; administrate atorvastatin 40 mg while the second group administrated rosuvastatin 20 mg.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Target level

  Baseline and 12 weeks

Study Arms (1)

The first group=atorvastatin on 40 mg/day,

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.

Drug: Atorvastatin 40 mg

Interventions

Atorvastatin 40 mg DRUG

Rosuvastatin 20 mg

The first group=atorvastatin on 40 mg/day,

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Heart Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (3)

• WHO. Global causes of deaths. 2021.

  BACKGROUND

• 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.

  PMID: 37740496 BACKGROUND

• 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.

  PMID: 40014670 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples (3 mL) were collected in EDTA-containing vacutainer tubes and stored at -80 °C until further analysis.

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Hosam Ali Mohamed, Professor

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate in Clinical Pharmacy

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 6, 2025
• Study Start: April 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: March 31, 2023
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)