CTRI/2014/01/004269
Completed
Phase 4
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.
Ranbaxy Laboratories Ltd0 sites500 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- â??very highâ?? risk or â??highâ?? risk patients, according to NCEP ATP III guidelines
- Sponsor
- Ranbaxy Laboratories Ltd
- Enrollment
- 500
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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