The upcoming PRE-EMPT clinical trial signals progress in addressing premature atherosclerosis through innovative approaches combining pharmaceutical interventions. Sponsored by leading institutions including Duke University and the National Heart, Lung, and Blood Institute (NHLBI), the trial aims to focus on preventive research into coronary artery disease risk factors and progression.
What is the purpose of the PRE-EMPT trial?
The PRE-EMPT (Prospective Randomized Evaluation and Management of Premature Atherosclerosis) clinical trial is designed to better understand methods for managing early-stage atherosclerosis, a major contributor to coronary artery disease, which remains a leading cause of morbidity and mortality worldwide. The study focuses on prevention and disease progression control in a population at high risk of premature atherosclerosis.
What interventions are being studied?
Three pharmaceutical interventions are central to the trial:
- Rosuvastatin 20 mg Oral Tablet: A potent statin used to lower cholesterol levels and reduce the risk of cardiovascular events.
- Colchicine 0.5 mg Oral Tablet Once Daily: An anti-inflammatory medication commonly used for gout but now being investigated for its potential benefits in reducing vascular inflammation.
- Placebo: Serving as a control to assess the statins and colchicine effects rigorously.
The combination aims to address inflammation and lipid regulation, two critical elements in atherosclerosis management.
Who is eligible for participation?
Enrollment has not yet begun as of November 18, 2025, but the trial seeks individuals with multiple coronary artery disease risk factors demonstrating early signs of disease progression. Exact inclusion and exclusion criteria will be disclosed closer to the recruitment launch, ensuring a carefully selected cohort to optimize the study’s reliability.
Frequently Asked Questions
1. What institutions are sponsoring the PRE-EMPT trial?
The trial is supported by Duke University, NHLBI, University of North Carolina, Chapel Hill, Massachusetts General Hospital, and Johns Hopkins University.
2. Where can I find updates on recruitment status?
Updates on recruitment and inclusion criteria will be shared on ClinicalTrials.gov.
3. How does this trial contribute to medical device advancements?
Though pharmaceutical-focused, the findings may inform design parameters for diagnostic devices monitoring disease progression.
Why does this matter?
The PRE-EMPT trial is poised to provide significant insights into managing premature atherosclerosis while contributing to advancements in both pharmaceutical and potential medical device strategies. Healthcare providers and researchers should follow its methodology closely for applicable clinical practice.
Disclaimer
This publication is intended for informational purposes only for professionals in clinical, regulatory, or quality roles. It does not constitute legal or medical advice.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07232069?term=medical+device