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

To evaluate the efficacy and safety of intensive dose of rosuvastatin, 40 mg/day, initiated early and continued for 12 weeks, in â??very highâ?? risk or â??highâ?? risk patients, according to NCEP ATP III guidelines, in Indian patients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2014/01/004269

Enrollment

500

Registered

2014-01-01

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- â??very highâ?? risk or â??highâ?? risk patients, according to NCEP ATP III guidelines

Interventions

Intervention1: Rosuvastatin 40 mg: Rosuvastatin 40 mg orally once daily for 12 weeks. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
ï?¼ The 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

Measure	Time frame
ï?¼ Safety 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?¼ The 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?¼ The 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?¼ The percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, non-HDL-CTimepoint: at 6 weeks, and at 12 weeks of treatment	—

Measure

Time frame

ï?¼ Safety 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?¼ The 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?¼ The 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?¼ The percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, non-HDL-CTimepoint: at 6 weeks, and at 12 weeks of treatment

—

Countries

India

Contacts

Public ContactDr Sachin Suryawanshi

Ranbaxy Laboratories Ltd

Sachin.Suryawanshi@ranbaxy.com02242916617

Outcome results

None listed

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