Comparison of single drug (rosuvastatin 40 mg)versus two drugs (rosuvastatin 20 mg and fenofibrate 145 mg) for the management of mixed dyslipidemia in patients with coronary artery disease.

To compare the efficacy and safety of combination of moderate dose rosuvastatin with fenofibrate with high dose rosuvastatin in patients of coronary artery disease with mixed dyslipidemia and high risk patients. Randomized controlled trial. - Mixed Dyslipidemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/01/007633

Enrollment

164

Registered

2017-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- MIXED DYSLIPIDEMIA WITH STABLE CORONARY ARTERY DISEASE AT HIGH RISK Health Condition 2: I52- Other heart disorders in diseasesclassified elsewhere

Interventions

Intervention1: Rosuvastatin (HMG CoA reductase inhibitor)-20 mg/day and Fenofibrate (PPAR-alfa activator)-145 mg/Day: Dose: 1. Rosuvastatin: 20 mg

tablet form 2. Fenofibrate: 145 mg

tablet form Route of administration: Oral Frequency of administration: Once in a day (Night, after dinner). Control Intervention1: Rosuvastatin (HMG CoA reductase inhibitor)-40 mg/day: Dose: 40 mg

tablet form Route of administration: Oral Frequency of administration: Once in a day (Night, after dinner).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18 - 70 years. 2. Patients with symptomatic stable CAD with mixed dyslipidemia (LDL-C level >100mg/dL & TG of >150mg/dL). 3. Willing to give informed consent for the study.

Exclusion criteria

Exclusion criteria: 1. Lipid levels below target goals off lipid lowering agent. 2. History of pancreatitis or cholelithiasis that has not been treated with cholecystectomy. 3. Patient on Hormonal Replacement Therapy or oral contraceptive pills. 4. Patient with Hepatic disease, renal disease. 5. Patients scheduled for CABG/PCI 6. H/O PCI/CABG within previous 3 months 7. Pregnant or lactating female. 8. H/O MI for less than 3 month. 9. Patient with the history of hypersensitivity for Rosuvastatin and Fenofibrate. 10. Type 1 diabetes mellitus or H/O Diabetic Ketoacidosis. 11. Uncontrolled type 2 diabetes mellitus defined as HbA1c >=8.5%. 12. History of diagnosed hereditary or acquired myopathy. 13. Unwilling or unable to give informed consent for the study.

Design outcomes

Primary

Measure	Time frame
Primary outcome: Proportion of patients achieving target goals of cholesterol in all the fractions of the lipoproteins defined as LDL-C of 70 mg/dl, Non HDL-C of 100 mg/dl, HDL-C 40 mg in men and 50 mg/dl in women and TG of 150mg/dl. Timepoint: 3 months	—

Secondary

Measure	Time frame
Secondary outcomes: â?ª Angina NYHA class â?ª Oxidative stress; levels of serum uric acid levels â?ª Systemic Blood Pressure â?ª ACS requiring admission â?ª Stroke â?ª All cause MortalityTimepoint: 3 months	—

Countries

India

Contacts

Public ContactDR PC Negi

INDIRA GANDHI MEDICAL COLLEGE

rbharti000@gmail.com8091006295

Outcome results

None listed

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