Rationale, design and baseline characteristics of a study to evaluate effects of candesartan on cardiovascular events after drug-eluting stent implantation in patients with ischemic heart disease

J Atheroscler Thromb. 2013;20(5):472-80. doi: 10.5551/jat.13870. Epub 2013 Mar 14.

Abstract

Aim: Few multicenter studies have assessed the effects of angiotensin receptor blockers on cardiovascular events after drug-eluting stent implantation in patients with ischemic heart disease.

Methods: An open-label multicenter randomized prospective study is in progress to evaluate the effects of candesartan on cardiovascular events in patients with ischemic heart disease after implantation of sirolimus- and/or paclitaxel-eluting stents.

Results: A total of 1,145 patients were enrolled at 39 institutes in the Candesartan for prevention of Cardiovascular events after CYPHER or TAXUS Coronary stenting (4C trial). Patients were randomized into a group treated with candesartan (n=602) and a group treated with standard medical therapy without candesartan (n=543). The primary endpoint of the 4C trial is a composite of all-cause death, successful resuscitation after cardiopulmonary arrest and cardiovascular events including non-fatal myocardial infarction, unstable angina requiring emergent hospitalization, congestive heart failure requiring emergent hospitalization and cerebrovascular attacks. All patients will be followed-up for 36 months.

Conclusions: The 4C trial will be the first multicenter study to elucidate the effects of candesartan after drug-eluting stent implantation and may provide new information to optimize medical therapy after percutaneous coronary interventions.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary
  • Angiotensin II Type 1 Receptor Blockers / therapeutic use*
  • Benzimidazoles / therapeutic use*
  • Biphenyl Compounds
  • Cardiovascular Diseases / prevention & control
  • Clinical Protocols
  • Combined Modality Therapy
  • Drug Discovery
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Myocardial Ischemia / drug therapy*
  • Myocardial Ischemia / therapy*
  • Paclitaxel / administration & dosage
  • Sirolimus / administration & dosage
  • Tetrazoles / therapeutic use*

Substances

  • Angiotensin II Type 1 Receptor Blockers
  • Benzimidazoles
  • Biphenyl Compounds
  • Tetrazoles
  • Paclitaxel
  • candesartan
  • Sirolimus