Conditions: Coronary Artery Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 57
Healthy volunteers: no

Brief summary:
The goal of this study is to determine if one dose of simvastatin will decrease the inflammatory response to coronary intervention. Also to determine if one dose of simvastatin affects endothelial function (activity of the artery) as measured by noninvasive peripheral artery tonography.

Detailed description:
The objective of this study is to determine if acute pretreatment with simvastatin, an HMG-CoA reductase inhibitor will reduce the post inflammatory response after percutaneous coronary interventions (PCI), and/or change endothelial function as assessed by peripheral arterial tomography (PAT). Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease.

Patients will be pretreated with simvastatin 80 mg prior to undergoing PCI. Endothelial function will be assessed before and after treatment via PAT. Our working hypothesis is patients pretreated with simvastatin, will have 1) attenuated inflammatory response, as noted by decreased levels of serum high sensitivity CRP and IL-6 and 2) improved endothelial function as compared to patients not pretreated with statin therapy.

Arms:
arm 1: Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention. arm 2: Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.

Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention. intervention 2: Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.

Protocol document: