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

Post-marketing study of clinical experience of Lipicure 80® (atorvastatin 80 mg) in patients with acute coronary syndromes Acronym: Cure - ACS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000687

Enrollment

160

Registered

2009-11-17

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- Acute Coronary Syndrome

Interventions

Intervention1: Lipicure80 &reg

(Atorvastatin 80 mg): Orally one tablet once daily for 12 weeks. Control Intervention1: Lipicure40 ® (Atorvastatin 40 mg): Orally one tablet once daily for 12 weeks.

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Percentage change in LDL-C at the end of treatment (12 weeks) from baselineTimepoint: 12 weeks	—

Secondary

Measure	Time frame
1)Percentage change in hs-CRP at the end of treatment (12 weeks) from baseline 2) Incidence of myotoxicity (i.e. evidence of muscle pain, soreness, weakness and/or cramps with or without CKP elevation) at the end of treatment (12 weeks) 3) Incidence of increase in liver enzymes (ALT & AST) ≥3 times UNL at the end of treatment (12 weeks) Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Hanmant Barkate

Intas Pharma

drbarkate@intaspharma.com66523259

Outcome results

None listed

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