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 range18 Years – 110 Years

SexALL

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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)
✕. Planned surgery within 30 days after the index procedure
✕. Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 36 months.
✕. Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
✕. Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
✕. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions

What they're measuring

MACE

Timeframe: 365 days

Trial details

NCT IDNCT04382443

SponsorCentro de estudios en Cardiologia Intervencionista

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-30

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