Oral Colchicine in Argentina to Prevent Restenosis (NCT04382443) | Clinical Trial Compass
CompletedPhase 4
Oral Colchicine in Argentina to Prevent Restenosis
Argentina410 participantsStarted 2020-03-12
Plain-language 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.
Who can participate
Age range
18 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject must be at least 18 to 80 years of age.
. Subject (or legal guardian) indicates understanding of the trial requirements and the treatment procedures and provides written informed consent before procedures are performed.
. Subject is eligible for PCI
. Subject has symptomatic coronary artery disease or silent ischemia with objective evidence of ischemia, or acute coronary syndromes, and qualifies for PCI
Exclusion criteria
. Subject has a known allergy to contrast (that cannot be adequately pre-medicated) and/or the stent system or Colchicine. (e.g., cobalt chromium alloy, stainless steel, all P2Y12 inhibitors, or aspirin)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MACE
Timeframe: 365 days
Trial details
NCT IDNCT04382443
SponsorCentro de estudios en Cardiologia Intervencionista