Conditions: Endothelial Dysfunction
Keywords: coronary endothelial dysfunction coronary vasospasm
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief summary:
AIM III is a prospective, randomized, double-blinded, placebo controlled trial. The study is directly connected to IRB 08-008161 as a specific aim of the National Institute of Health (NIH) grant. Participants may either consent to and qualify for AIM I and AIM II (IRB 08-008161) or have a cardiac catheterization with acetylcholine testing in the Cardiac Catheterization Laboratory at Mayo Clinic in Rochester, Minnesota to be considered for this study.

Detailed description:
The main goal of AIM III is to assess and quantify the effect of long-term administration of darapladib 160 mg once a day, a selective, reversible, orally active inhibitor of plasma and vascular Lp-PLA2, on coronary endothelial function, progression of coronary atherosclerosis as determined by intravascular ultrasound (IVUS), and atherosclerosis in patients with early atherosclerosis. Patients with evidence of coronary endothelial dysfunction, as determined by intracoronary administration of acetylcholine during angiography and IVUS, will be followed for 6 months during once daily dosing of darapladib. Coronary endothelial function is determined by the changes in coronary artery diameter and coronary blood flow response to the intracoronary administration of acetylcholine and adenosine. The patients will be followed in clinic 6 months. They will have follow-up angiography, assessment of endothelial function, and IVUS during the six month visit.

Arms:
arm 1: Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months. arm 2: Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.

Interventions: intervention 1: darapladib intervention 2: placebo
Intervention descriptions: intervention 1: darapladib, tablet, 160 mg, by mouth, one time daily, 6 month duration intervention 2: placebo, by mouth, once daily for six months

Protocol document: