Oral Colchicine in Argentina to Prevent Restenosis (ORCA)

Oral Colchicine in Argentina (ORCA Trial) for the Prevention of Adverse Events After Percutaneous Coronary Interventions

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Atherosclerosis; Acute Coronary Syndrome; Restenosis of Coronary Artery Stent
• Intervention / Treatment: Drug: Colchicine

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 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 clinical parameters (not angiographic) of restenosis (ERACI III trial, one year TVR in 8.8% with 1st DES design, Rodriguez A et al EuroIntervention 2006,2:53-60 and 4.0% with 2nd generation DES design ERACI IV Cardiac and cardiovascular interventions Journal, 2014 ). Taking in account those numbers the investigators sought to compare differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of follow up assuming that safety and efficacy clinical end points would be similar. Cost included in hospital, procedural and resources fees, follow up cost including re-hospitalization driving by target vessel revascularization (TVR) and both spontaneous and TVR myocardial infarction (MI) and medication cost for each revascularization strategies Safety end point will be incidence of major adverse cardiac events (MACE) defined as the composite of death from any cause, MI (peri-procedural and spontaneous at follow up) and ischemic driving TVR.

The study will be considered complete after all subjects have completed the 12-month Primary safety and efficacy endpoint was incidence of target vessel failure (TVF) plus one year overall cost with both strategies.. Additional end points are clinical endpoints measured in-hospital at at follow up period. cardiac death, cardiac death plus MI. spontaneous MI beyond 30 day to 5 years, and stent thrombosis rate (ST) (definite or probable by Academic Research Consortium definitions).

A sub-study of changes in biological markers of inflammation in patients with acute coronary syndrome (ACS) including MI will be analyzed in both groups. For this reason, a measurement of interleukin 6, metalloproteases, adiponectin and Protein C reactive (PCR) will be performed at the time of enrolment and 4 days and a month after inclusion.

• Study Type: Interventional
• Enrollment (Actual): 410
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad de Buenos Aires, Buenos Aires, Argentina, 1126
      • Sanatorio Otamendi
    • San Isidro, Buenos Aires, Argentina, 1111
      • Sanatorio Las Lomas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Colchicine +BMS implantation; This group will receive after BMS and Colchicine, at the time of PCI, 0,5 mg twice a day during the first three months after stent implantation	Drug: Colchicine; At the moment of BMS implantation intervention will mean that this group will receive colchicine as described.; Other Names: BMS+Colchicine
No Intervention: Second generation Drug eluting stent (DES); This group will receive DES at the moment of randomization and will be treated as standard of care. All second generation DES should be approved by ANMAT for clinical use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	MACE: Was defined as a composite of death, Myocardial infarction (MI) Stroke, stroke and ischemic target vessel revascularization (TVR) Death included cardiac, non- cardiac and non- determined. MI included STEMI with new q waves at the EKG and /or 5 times increase cardiac enzymes elevation for baseline levels. NSTEMI included 5 times enzymes elevation with non- new Q waves. TVR included repeat revascularization in the target vessel initially treated driving by new chest pain and / or perfusion ischemic changes at ergometric or perfusion test.	365 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion failure	Target lesion failure (TLF): TLF was defined as cardiac death, MI and ischemic driving revascularization (TLR) of initially treated lesion.	365 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes C-Reactive Protein (CRP) values	Normal values: 0 to 5 mg/L	baseline, 4 and 30 days
Changes in Adinopectine values μU/mL	Normal values in women 4,62±1,57 vs In men 3,93±1,86 μU/mL	baseline and 30 days
Changes in Interleukin 6 values (pg/m)	Normal values IL-6 (5-15 pg/ml)	baseline and 30 days

Collaborators and Investigators

• Sponsor: Centro de estudios en Cardiologia Intervencionista
• Investigators: Study Chair: Alfredo E Rodriguez, MD, PhD, Centro de estudios en Cardiologia Intervencionista

Publications and helpful links

General Publications

• Correa-Sadouet C, Rodriguez-Granillo AM, Gallardo C, Mieres J, Fontana L, Curotto MV, Wainer P, Allende NG, Fernandez-Pereira C, M Vetulli H, la Hoz RP, Kastrati A, Rodriguez AE; ORCA investigators. Randomized comparison between bare-metal stent plus colchicine versus drug-eluting stent alone in prevention of clinical adverse events after percutaneous coronary intervention. Future Cardiol. 2021 Jul;17(4):539-547. doi: 10.2217/fca-2020-0161. Epub 2020 Nov 11.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; acute coronary syndrome; atherosclerosis; inflammation; colchicine; restenosis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Atherosclerosis; Acute Coronary Syndrome; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Gout Suppressants; Antirheumatic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Colchicine
• Other Study ID Numbers: CECI-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All researchers that want to work with the database must sign a confidentiality form and all legal documents applicable for the time being.
• IPD Sharing Time Frame: From May 2020 to December 2022
• IPD Sharing Access Criteria: Researcher with approved HIPPA compliant certificates. Accept to sign confidentiality form. Do not publish content without autorization of the Sponsor or Chair of the trial.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No