Intensive statin therapy for Chinese patients with coronary artery disease undergoing percutaneous coronary intervention (ISCAP study): rationale and design

Catheter Cardiovasc Interv. 2012 May 1;79(6):967-71. doi: 10.1002/ccd.23171. Epub 2011 Oct 5.

Abstract

Background: Myocardial necrosis is related to higher incidence of cardiovascular events and higher mortality rates during follow-up. Statins have been demonstrated to lower the risk of periprocedural myocardial infarction. The aim of this study is to evaluate the safety and efficacy of intensive statin therapy and the long-term outcome of patients in the Asian population.

Study design: Approximately 1,100 patients with stable angina or non-ST elevation acute coronary syndrome undergoing selective percutaneous coronary intervention (PCI) are enrolled in this study. Patients are randomized either to the experimental group (80 mg atorvastatin 80 mg/day × 2 days before and 40 mg/day × 30 days after PCI) or to the control group (usual care). Creatine kinase-MB (CK-MB), troponin I (cTnI), and serum creatine are measured at 24 hours after the procedure. The total follow-up period is 6 months. The primary objective is to evaluate the efficacy of intensive atorvastatin treatment compared with usual care in reducing 30-day primary cardiovascular endpoints in patients undergoing selective PCI. Secondary endpoints are changes in myocardial biomarkers (cTnI, CK-MB) and hs-CRP, CIN morbidity, 6-month clinical outcomes, and safety.

Conclusion: The result of the ISCAP study will provide important evidence on the efficacy and safety of periprocedural serial intensive statin treatment in Asian patients with coronary artery disease undergoing selective PCI.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angioplasty, Balloon, Coronary* / adverse effects
  • Angioplasty, Balloon, Coronary* / mortality
  • Asian People
  • Atorvastatin
  • Biomarkers / blood
  • C-Reactive Protein / metabolism
  • Cardiovascular Diseases / blood
  • Cardiovascular Diseases / etiology
  • Cardiovascular Diseases / mortality
  • Cardiovascular Diseases / prevention & control*
  • China / epidemiology
  • Coronary Artery Disease / drug therapy
  • Coronary Artery Disease / ethnology
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Creatine / blood
  • Creatine Kinase, MB Form / blood
  • Drug Administration Schedule
  • Heptanoic Acids / administration & dosage*
  • Heptanoic Acids / adverse effects
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects
  • Pyrroles / administration & dosage*
  • Pyrroles / adverse effects
  • Research Design*
  • Time Factors
  • Treatment Outcome
  • Troponin I / blood

Substances

  • Biomarkers
  • Heptanoic Acids
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Pyrroles
  • Troponin I
  • C-Reactive Protein
  • Atorvastatin
  • Creatine Kinase, MB Form
  • Creatine