to see the effect and safety of rosuvastatin 40mg/day started early.

Phase 4

Completed

• Conditions: Health Condition 1: null- â??very highâ?? risk or â??highâ?? risk patients, according to NCEP ATP III guidelines

• Registration Number: CTRI/2014/01/004269
• Lead Sponsor: Ranbaxy Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

i.Adult patients (30 to 69 years of age) with evidence of coronary artery disease, who are hospitalized with recent chest pain (ischemic symptoms) with or without ECG changes.

ii.Patients with non-ST segment elevation ACS and ST segment elevation ACS who received optimal reperfusion therapy are eligible.

Exclusion Criteria

i.Patients with LDL-C level 70 mg/dL (Very High Risk) and 100 mg/dL (High Risk)

ii.Receiving intensive lipid-lowering therapy of Rosuvastatin 40 mg for 3 months before admission

iii.Active liver disease or dysfunction indicated by levels of alanine aminotransferase (ALT) 3 Ã? upper limit of normal (ULN)

iv.Unexplained serum creatine kinase (CK) level 3 Ã? ULN;

v.Serum creatinine 2.0 mg/dL;

vi.History of hypersensitivity to statins

vii.Pregnant and lactating women

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ï?¼The percent change from baseline in LDL-C levels at Baseline, 6, and 12 weeks of treatment.Timepoint: at 6 weeks, and at 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
ï?¼Safety and tolerability by evaluating the incidence and severity of adverse events (AEs), and abnormal laboratory valuesTimepoint: at 6 weeks, and at 12 weeks of treatment;ï?¼The LDL-C goals for patients in each risk level were set according to the updated version of NCEP ATP III: 100 mg/dL for high risk group; and 70 mg/dL for very high risk group. The proportion of patients reaching goals according to different risk levelsTimepoint: at 6 weeks and at 12 weeks;ï?¼The percent change from baseline in the level of high sensitivity C-reactive protein (hsCRP), an inflammatory marker, over 6 to 12 weeks of treatment,Timepoint: at 6 weeks, and at 12 weeks of treatment;ï?¼The percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, non-HDL-CTimepoint: at 6 weeks, and at 12 weeks of treatment