Status:
COMPLETED
Oral Colchicine in Argentina to Prevent Restenosis
Lead Sponsor:
Centro de estudios en Cardiologia Intervencionista
Conditions:
Coronary Artery Disease
Restenosis of Coronary Artery Stent
Eligibility:
All Genders
18-110 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
In a previous randomized comparison oral colchicine plus bare metal stent (BMS) compared to BMS plus placebo in a diabetic High risk for re-stenosis population, OC demonstrate a significant reduction ...
Eligibility Criteria
Inclusion
- Clinical and angiographic
- 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
- 6\. Subject has a left ventricular ejection fraction (LVEF) \> 40 % as measured within 60 days prior to enrollment.
- 7\. Subject is willing to comply with all protocol-required follow-up evaluations.
- 8\. Subject has one or more coronary artery stenosis of ≥ 70 % in a coronary artery with visually estimated reference vessel diameter (RVD) ≥2.50 mm.
Exclusion
- Clinical and angiographic
- 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
- 5\. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint, or that, in the opinion of the investigator, may cause non-compliance with the protocol or confound data interpretation.
Key Trial Info
Start Date :
March 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT04382443
Start Date
March 12 2020
End Date
April 30 2022
Last Update
July 14 2025
Active Locations (2)
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1
Sanatorio Otamendi
Ciudad de Buenos Aires, Buenos Aires, Argentina, 1126
2
Sanatorio Las Lomas
San Isidro, Buenos Aires, Argentina, 1111