Stabilisation of Atherosclerotic Plaque with Darapladib Therapy

• Research type

  Research Study

• Full title

  A clinical outcomes study of darapladib versus placebo in subjects with chronic coronary heart disease to compare the incidence of major adverse cardiovascular events (MACE)

• IRAS ID

  9044

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2008-005575-96

• Clinicaltrials.gov Identifier

  00799903

• Research summary

  Coronary heart disease (CHD) remains one of the main causes of death in Europe, USA and Canada. Current medical advice for the prevention of CHD consists of making improvements to lifestyle including diet, exercise and smoking cessation. The addition of drug treatments is designed to control blood pressure, reduce lipid levels and inhibit platelet function (to prevent blood clotting and potentially causing heart attacks or stroke). The enzyme Lp-PLA2, is associated with the oxidation of LDL cholesterol, inflammation and plaque instability and therefore, cardiovascular events. Darapladib has been shown in a previous study (LPL104884) to inhibit Lp-PLA2 activity and this may therefore reduce vascular inflammation and promote the stability of atherosclerotic plaques. Darapladib has also been shown to modify the progression of plaques in the coronary arteries (IBIS 2). In this study, approximately 15,500 subjects with CHD and receiving standard of care, will be recruited and given either darapladib 160mg or placebo. All participants will be monitored for cardiovascular events. It is proposed that darapladib which has been shown to inhibit the enzyme Lp-PLA2, may provide additional medical benefits to patients with established CHD at high risk of cardiovascular events who are already taking standard therapy including statins. By adding darapladib to participants routine treatment for CHD and comparing this to a group taking routine treatment only, we hope to show that taking darapladib in addition to routine treatment can lower the incidence of major cardiovascular events such as a heart attack or a stroke.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  08/H0706/130

• Date of REC Opinion

  8 Jan 2009

• REC opinion

  Further Information Favourable Opinion