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Phased Multi-Site Clinical Trial: Testing Prevention of Cardiovascular Disease in Young Adults With High Lifetime Risk Using Surrogate Outcomes - Data Coordinating Center (Collaborative U24 Trial Required)

National Institutes of Health

The goal of this Notice of Funding Opportunity (NOFO) is to support a clinical trial which will test intervention(s) to reduce the progression of coronary atherosclerosis among young adults who are at low or borderline 10-year risk (<7.5%) for their first atherosclerotic cardiovascular disease (ASCVD) event, yet at high lifetime risk of developing cardiovascular disease (CVD). For the purpose of this NOFO, “young adults” is defined as less than or equal to 50 years for men, and given the lower rate of coronary atherosclerosis before menopause for women compared to men, it may be reasonable to use an expanded inclusion criteria to include women older than age 50.

This opportunity will support a two component 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. Trial participants who are identified as meeting the subclinical coronary atherosclerosis criteria for enrollment in the screening component will be immediately enrolled in the intervention, even though component one recruitment continues until the trial is completely enrolled.

It is expected that the trial will have three arms. One will be a control or comparison arm. The control arm is expected to be current guideline-based behavioral and pharmacological interventions. One of the two active arms is expected to involve an additional pharmacological intervention(s) with definite evidence of efficacy for primary prevention in older high-risk adults, such as LDL-lowering therapy. The other active arm may involve intervention(s) with less definitive evidence of primary prevention efficacy in older adults. The goal of this research strategy is to determine if earlier treatment of subclinical ASCVD will reduce adverse clinical events to a greater degree than current guideline-recommend treatment.

This NOFO will support applications to develop and implement a Data Coordinating Center (DCC) for a multi-site clinical trial among young adults without clinical ASCVD. It will utilize a milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO that encourages applications for a collaborating Clinical Coordinating Center ( RFA-HL-25-010 ). The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application. The application should also describe its approaches to collaborate with the CCC ( RFA-HL-25-010 ) on implementation of the clinical trial community engagement and diversity plans, as well as reducing health inequities. Clinical trials using innovative designs such as platform trials, adaptive, and Bayesian designs are welcomed.

Both a CCC application and a collaborating Data Coordinating Center (DCC) application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contacts prior to applying.

This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).

Deadlines:

Letter of Intent Due Date(s): September 9, 2024
Application Due Date: October 28, 2024

RFA-HL-25-007 Expiration Date October 29, 2024

Specialties

Medical

Medical - Clinical Science

Eligibility Requirements

Multiple PDs/PIs are allowed on any single application. PD(s)/PI(s) from each linked application should not be designated as multiple PDs/PIs on each application of a collaborative set.

ESI applicants can be the PI/PD of an application providing they can show support of investigators with appropriate clinical trials experience (as part of a multiple PI team). ESIs are encouraged to be part of the study team, and they should be budgeted for support at a level appropriate for the role on the project.

This NOFO only accepts an application that is part of a collaborative pair of applications. The pair must include one application to this DCC U24 NOFO plus one application to the companion CCC UG3/UH3 NOFO, RFA-HL-25-010 .