Rationale and design of a trial on the effect of high dose statins on cardiovascular risk in adults after successful coarctation repair

Contemp Clin Trials. 2012 Mar;33(2):410-6. doi: 10.1016/j.cct.2011.11.011. Epub 2011 Nov 13.

Abstract

Background: HMG-coA-reductase-inhibitors (statins) have been proven to reduce atherosclerosis progression as observed by carotid intima-media thickness in patients with known coronary heart disease, independent of lipid lowering. Cardiovascular complications are common in patients after successful coarctation repair. The effect of statins on cardiovascular risk in adults after successful coarctation repair has not yet been established.

Methods: We designed a multicentre, prospective, randomised, open label trial to evaluate the effect of the HMGcoA-reductase-inhibitor (Atorvastatin) on atherosclerotic progression in adult post-coarctectomy patients. The primary endpoint in this study is the carotid intima-media thickness as measured by Bmode ultrasonography of the carotid arteries.

Conclusion: This large prospective, randomised, open label trial will establish the effect of HMG-coA-reductase inhibitors (Atorvastatin) on cardiovascular risk in adult patients after successful coarctation repair.

Publication types

  • Historical Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aortic Coarctation / complications
  • Aortic Coarctation / surgery*
  • Atherosclerosis / complications
  • Atherosclerosis / diagnostic imaging
  • Atherosclerosis / drug therapy*
  • Atorvastatin
  • Cardiac Surgical Procedures*
  • Carotid Arteries / diagnostic imaging*
  • Disease Progression
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Heptanoic Acids / administration & dosage*
  • History, Ancient
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
  • Male
  • Postoperative Care / methods*
  • Prospective Studies
  • Pyrroles / administration & dosage*
  • Treatment Outcome
  • Ultrasonography

Substances

  • Heptanoic Acids
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Pyrroles
  • Atorvastatin