drugset / Trial / NCT04382443
Oral Colchicine in Argentina to Prevent Restenosis
RandomizedParallel-groupOpen-labelTreatment
Summary
The Oral treatment of Colchicine in Argentina (ORCA) trial is a prospective, randomized, multicenter trial to included 450 patients with indication for myocardial revascularization with PCI between a group to be treated with BMS plus oral colchicine (OC) for three months, which should be administered at the time of PCI, these patients they would receive 0.5 mg twice a day per 3 months compared to the other group of patients who will be treated exclusively with last generation of DES.
Timeline
- Start
- 2020-03-12
- Primary completion
- 2022-04-30
- Completion
- 2022-04-30
Publications
- Results Correa-Sadouet C, Rodriguez-Granillo AM, Gallardo C, Mieres J, Fontana L, Curotto MV, Wainer P, Allende NG, Fernandez-Pereira C, M Vetulli H, la Hoz RP, Kastrati A, Rodriguez AE; ORCA investigators. Randomized comparison between bare-metal stent plus colchicine versus drug-eluting stent alone in prevention of clinical adverse events after percutaneous coronary intervention. Future Cardiol. 2021 Jul;17(4):539-547. doi: 10.2217/fca-2020-0161. Epub 2020 Nov 11.
- Rodriguez-Granillo AM, Mieres J, Fernandez-Pereira C, Sadouet CC, Milei J, Swieszkowski SP, Stutzbach P, Santaera O, Wainer P, Rokos J, Gallardo C, Cristodulo-Cortez R, Perez de la Hoz R, Kastrati A, Rodriguez AE, On Behalf Of Orca Investigators. Randomized Clinical Trial Comparing Bare-Metal Stents Plus Colchicine Versus Drug-Eluting Stents for Preventing Adverse Cardiac Outcomes: Three-Year Follow-Up Results of the ORal Colchicine in Argentina (ORCA) Trial. J Clin Med. 2025 Apr 22;14(9):2871. doi: 10.3390/jcm14092871.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colchicine | Small molecule | 0.5 mg | Oral |