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

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 succ...

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Bibliographic Details
Published in:Contemporary clinical trials 2012-03, Vol.33 (2), p.410-416
Main Authors: Luijendijk, Paul, Bouma, Berto J, Vriend, Joris W.J, Groenink, Maarten, Vliegen, Hubert W, de Groot, Eric, Pieper, Petronella G, van Dijk, Arie P.J, Sieswerda, Gertjan T, Veen, Gerrit, Zwinderman, Aeilko H, Mulder, Barbara J.M
Format: Article
Language:English
Subjects:
Adult
Aortic coarctation
Aortic Coarctation - complications
Aortic Coarctation - surgery
Atherosclerosis - complications
Atherosclerosis - diagnostic imaging
Atherosclerosis - drug therapy
Atorvastatin Calcium
Cardiac Surgical Procedures
Cardiovascular
Carotid Arteries - diagnostic imaging
Carotid intima-media thickness (CIMT)
Disease Progression
Dose-Response Relationship, Drug
Female
Follow-Up Studies
Hematology, Oncology and Palliative Medicine
Heptanoic Acids - administration & dosage
History, Ancient
HMG-coA-reductase-inhibitors (statins)
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage
Male
Postoperative Care - methods
Premature atherosclerosis
Prospective Studies
Pyrroles - administration & dosage
Treatment Outcome
Ultrasonography
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Summary: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.
ISSN:1551-7144
1559-2030
DOI:10.1016/j.cct.2011.11.011