STABILITY

The STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY

This is a randomised, placebo-controlled, double-blind, parallel group, multi centre, event driven trial of an investigational product called darapladip, in people with chronic coronary heart disease receiving standard practice care at the time of entry into the study.  Coronary heart disease (CHD) is a condition in which deposits of fat and cholesterol, called plaque, build up over time in the heart or the blood vessels that supply blood to the heart muscle.  This build up of plaque is part of a process called “atherosclerosis”, or hardening of the arteries.  People with CHD are at risk of having a heart attack or stroke.

Darapladip reduces the activity of a naturally occurring chemical in the body, an enzyme, called lipoprotein-associated phospholipase A₂, or Lp-PLA₂.  Elevated plasma levels of an enzyme known as Lp-PLA₂ are associated with an increased risk of cardiovascular events.  Clinical studies of darapladip have shown dose-dependent inhibition (the higher the dose the greater the inhibition) of both plasma and intra-plaque Lp-PLA₂ activity.  Stopping the production of this enzyme may be beneficial to cardiovascular patients who are also taking standard therapies such as lipid lowering medication called statins.

This international study aimed to recruit 15,500 participants randomised to one of two groups.  Approximately 7,750 participants will be allocated to the darapladip group and will receive 160mg of enteric coated darapladip daily, 7,750 participants will receive a placebo daily and will be followed for up to 3 years.  The study recruitment was achieved in October 2009, with 306 participants at 16 sites in Australia (23 participants were recruited by the Clinical Trial Centre – the second highest recruiting site in Australia). Study participants will be followed every 6 months for approximately 3½ years.  This study is funded by the pharmaceutical company, GlaxoSmithKline.