drugset / Trial / NCT06342609
Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease
Phase 4
Completed
84 enrolled
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
RandomizedParallel-groupTriple-blindHealth-services research
Summary
This is a randomized double-blind, placebo-controlled, investigator-initiated trial that compares Colchicine 0.5mg/day with placebo, among patients with stable CAD. Subjects will be educated to maintain medication compliance with other prescribed medications.
Timeline
- Start
- 2023-03-15
- Primary completion
- 2024-09-07
- Completion
- 2024-09-07
Publications
- Budoff MJ, Bhandari M, Iskander B, Ghanem AK, Kinninger A, Stark J, Garikapati V, Chilukuri S, Hankil V, Krishnan S, Punnanithinont N, Ichikawa K, Kambalapalli S, Hamal S, Lakshmanan S. Effect of colchicine on progression of known coronary atherosclerosis in patients with stable coronary artery disease: EKSTROM randomized placebo controlled trial. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):682-692. doi: 10.1093/ehjci/jeag028.
- Verghese D, Hamal S, Ghanem A, Kinninger A, Javier D, Ichikawa K, Benzing T, Krishnan S, Kianoush S, Hamidi H, Bagheri M, Abraham D, Deljavanghodrati M, Ghoto A, Aldana-Bitar J, Budoff M. Effect of colchicine on progression of known coronary atherosclerosis in patients with STable CoROnary artery disease CoMpared to placebo (EKSTROM) trial-rationale and design. Am Heart J. 2024 Nov;277:20-26. doi: 10.1016/j.ahj.2024.07.005. Epub 2024 Jul 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Colchicine | Small molecule | 0.5 mg | Oral |