ACTIVATE Trial

Study of:
Study drug vs. placebo; sponsored by Sankyo Pharma Development
 
Cardiovascular disease in the leading cause of death in the United States, accounting for 750,000 deaths each year. Previous studies have shown that elevated plasma levels of total cholesterol are risk factors for developing cardiovascular disease. The process of atherosclerosis (buildup in the artery) likely begins during adolescence. Once plaque forms in the artery, there is potential for it to rupture causing an acute coronary event (heart attack). Therefore it is important to prevent the formation and progression of atherosclerotic disease. This new drug is believed to help reduce the progression of atherosclerosis.

This randomized, double blind, placebo controlled trial will evaluate the efficacy and safety of this new drug to reduce the progression of atherosclerosis in patients with coronary artery disease. This study will be conducted at 50-60 study sites across the United States. Approximately 480 patients will participate. Patients will be asked to take the study medication (study drug or a placebo) once daily in the morning and follow-up every 3 months over a period of 18-months. The follow up procedures include lab work, dietary compliance, exams and electrocardiograms. At the end of the eighteen months, patients will return for an 18-month angiogram and intravascular ultrasound procedure (an ultrasound that looks at the inside of the cardiac vessel) to evaluate atherosclerosis within the coronary arteries.

• M. Nicholas Burke, MD
• Ivan J. Chavez, MD, FACC
• Timothy D. Henry, MD, FACC
• John R. Lesser, MD, FACC
• Daniel Lips, MD, FACC
• James D. Madison, MD, FACC
• Michael R. Mooney, MD, FACC
• Wesley R. Pedersen, MD, FACC 
• Anil K. Poulose, MD, FACC
• Jay H. Traverse, MD, FACC, FAHA 
• Yale Wang, MD, FACC, FSCAI

• Holly MacDonald, RN
• Talia Pierce, RN

For more information about this or other research studies at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact Holly MacDonald at 612-863-6051.