Oral Colchicine in Argentina to Prevent Restenosis

Launched by CENTRO DE ESTUDIOS EN CARDIOLOGIA INTERVENCIONISTA · May 8, 2020

Keywords

ClinConnect Summary

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 of angiographic and intravascular ultrasound parameters of in-stent restenosis (ISR) after BMS implantation at one year of follow up (Journal of the American College of Cardiology,2013,61,1678-1685), with a clinical indication of target lesion revascularization in 3.6%. In addition previous reported registries from our group with Drug Eluting Stents showed similar amount of reduction in clinica...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Clinical and angiographic
• • 1. Subject must be at least 18 to 80 years of age.
• • 2. Subject (or legal guardian) indicates understanding of the trial requirements and the treatment procedures and provides written informed consent before procedures are performed.
• • 3. Subject is eligible for PCI
• • 4. 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 Criteria:
• • Clinical and angiographic
• • 1. 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)
• • 2. Planned surgery within 30 days after the index procedure
• • 3. Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 36 months.
• • 4. Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
• • 5. Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
• • 6. 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.