Clinical Trial Considerations in the Development of Inhibitors of Cardiovascular Plaque Rupture

Great strides have been made in the last decade in dissecting the molecular and cellular mechanisms leading to rupture of atherosclerotic plaque. As inhibitors of the cellular and molecular events leading to plaque rupture are developed, it is in the interest of public health to make them available to patients as expeditiously as possible. This chapter reviews the principles of clinical trial design and the steps required to demonstrate the safety and efficacy of new compounds intended to prevent plaque rupture.