Abstract 14710: The Landscape of Pharmacological Interventional Trials for the Treatment or Prevention of Coronary Artery Disease: Analysis of clinicaltrials.gov Listings From 2008 to 2022
Gerald Chi, Cecilia Bahit, Serge Korjian, Laith Allaham, Syed Hassan A. Kazmi, Paul Nara, Alka Shaunik, Charles Gibson- Physiology (medical)
- Cardiology and Cardiovascular Medicine
Background: Coronary artery disease (CAD) has been the leading cause of death and disability over the past two decades.
Aims: To systematically assess the characteristics and trends of clinical trials pertaining to the treatment or prevention of CAD.
Methods: The analysis included studies that (1) were registered in the ClinicalTrials.gov database from 2008 to 2022; (2) involved ≥1 pharmacological intervention; and (3) were designed to treat or prevent CAD or its complications. Study records were downloaded on December 27, 2022 for screening and analysis. Pharmacological interventions were classified according to the World Health Organization Anatomical Therapeutic Chemical Classification System. Annual trends by the year of study registration were assessed with a two-sided Cochran-Armitage test.
Results: A total of 1,619 trials were identified from a pool of 437,319 studies. There was a declining trend in the number of CAD trials (Figure A). The majority of trials (47.5%) were targeted to enroll ≤100 participants, while 39.4% targeted 101-1000 participants, 10.5% targeted 1001-5000 participants, and 2.6% were mega-trials (>5000 participants). The distribution of study duration was as follows: ≤12 months (25.3%), 13-60 months (67.3%), and >60 months (7.5%). Of note, the open-label design was more commonly employed in treatment trials (41.8% vs. 31.6%; p=0.02), while the parallel assignment was more frequently utilized in prevention trials (88.8% vs. 82.0%; p=0.03). In addition, declining trends in the proportions of phase 3 trials (p=0.0008; Figure B) and trials of lipid-modifying (p=0.0043) or anti-thrombotic agents (p=0.03; Figure C) were observed.
Conclusion: Between 2008 and 2022, the clinical trial landscape of CAD diminished and was mainly shaped by studies with small to moderate sample sizes and short to intermediate follow-up duration. Research focus trended toward study interventions other than anti-thrombotic or lipid-modifying agents.