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.

Phase 4

Completed

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

• Registration Number: CTRI/2017/01/007633
• Lead Sponsor: INDIRA GANDHI MEDICAL COLLEGE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-05-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 165

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>Timepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes: <br/ ><br>â?ª Angina NYHA class <br/ ><br>â?ª Oxidative stress; levels of serum uric acid levels <br/ ><br>â?ª Systemic Blood Pressure <br/ ><br>â?ª ACS requiring admission <br/ ><br>â?ª Stroke <br/ ><br>â?ª All cause MortalityTimepoint: 3 months