A study of the clinical experience with atorvastatin 80 mg in patients with acute coronary syndromes (heart attack )

Phase 4

Completed

• Conditions: Health Condition 1: null- Acute Coronary Syndrome

• Registration Number: CTRI/2009/091/000687
• Lead Sponsor: Intas Pharmaceuticals Limited

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: 160

Inclusion Criteria

1) Patients of either gender in the age group of 18- 75 years of age group

2) Diagnosed case of acute coronary syndromes (acc. to ACC/AHA practice guidelines)- (patients with TIMI score >=3)

3) Hospitalized or diagnosed for ACS within last 10 days

4) Stabilized patients i. e. without heart failure.

5) Patients or whose guardians/ legally acceptable representatives, are willing to sign an informed consent document, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria

1) Current therapy with highest therapeutic dose of any statin including atrovastatin 80 mg
2) CABG within the previous 2 months or scheduled to undergo bypass surgery
3) Liver dysfunction ( ALT &/or AST more than 2 times ULN)
4) Creatinine phosphokinase (CKP) elevation more than 3 times the ULN
5) Renal impairment (Serum creatinine levels more than 2.0 mg /dl)
6) Patients on drugs which are strong inhibitors of cytochrome p450 3 A4 enzymes like macrolid antibiotics (such as erythromycin, roxithromycin etc.), azole antifungals ( ketoconazole, fluconazole etc.) , cyclosporine, gemfibrozil etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified