Oral Colchicine in Argentina to Prevent Restenosis

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro de estudios en Cardiologia Intervencionista
• Treatments: Colchicine

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.