Phased Multi-Site Clinical Trial: Testing Prevention of Cardiovascular Disease in Young Adults With High Lifetime Risk Using Surrogate Outcomes - Clinical Coordinating Center (Collaborative UG3/UH3 Clinical Trial Required)

The goal of this funding opportunity for a Clinical Coordinating Center is to support a clinical trial which will test intervention(s) to reduce the progression of coronary atherosclerosis among young adults under the age of fifty years old who are at low or borderline 10-year risk ( 7.5%) for their first an atherosclerotic cardiovascular disease (ASCVD) event, yet at high lifetime risk of developing cardiovascular disease (CVD). This opportunity will support a two-phased primary prevention clinical trial that will first efficiently screen the appropriate population eligible for the intervention and second determine which intervention(s) are most efficacious at reducing the onset or slowing the progression of subclinical coronary atherosclerosis. It is expected that phase one will overlap with phase two. Trial participants who are identified as meeting the subclinical coronary atherosclerosis criteria for enrollment in the screening stage will be immediately enrolled in stage two even although stage one recruitment will continue until the trial is completely enrolled. It is expected that the trial will have three arms. One will be a control or comparison arm and the second and the third arm will test different interventions than the control arm. The control arm should be current guideline based behavioral interventions. One of the two non-control arms is expected to involvement pharmacological intervention(s) with definite evidence of efficacious for primary prevention in older high risk adults such as LDL- lowering therapy and the other arm may involve intervention(s) with less definite evidence of primary prevention efficacy in older adults The long range goal of this research strategy is to determine if earlier treatment prevents more CVD than current guideline recommended treatment. Applications for both a CCC and a DCC must be submitted on the same application due date for consideration by NHLBI.