Oral Colchicine in Argentina to Prevent Restenosis

NCT04382443 | Completed Phase 4 DMC

• 1 other identifier: CECI-03
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Coronary Artery Disease; Restenosis of Coronary Artery Stent; Atherosclerosis; Acute Coronary Syndrome

Keywords

restenosis; atherosclerosis; acute coronary syndrome; percutaneous coronary intervention; colchicine; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Target lesion failure

  365 days

Other Outcomes (3)

• Changes C-Reactive Protein (CRP) values

  baseline, 4 and 30 days

• Changes in Adinopectine values μU/mL

  baseline and 30 days

• Changes in Interleukin 6 values (pg/m)

  baseline and 30 days

Study Arms (2)

Oral Colchicine +BMS implantation

EXPERIMENTAL

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

Second generation Drug eluting stent (DES)

NO INTERVENTION

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.

Interventions

Colchicine DRUG

At the moment of BMS implantation intervention will mean that this group will receive colchicine as described.

Also known as: BMS+Colchicine

Oral Colchicine +BMS implantation

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. Subject has a left ventricular ejection fraction (LVEF) \> 40 % as measured within 60 days prior to enrollment.
• \. Subject is willing to comply with all protocol-required follow-up evaluations.
• \. Subject has one or more coronary artery stenosis of ≥ 70 % in a coronary artery with visually estimated reference vessel diameter (RVD) ≥2.50 mm.

You may not qualify if:

• 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
• \. 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.

Sponsors & Collaborators

• Centro de estudios en Cardiologia Intervencionista: lead

Study Sites (2)

Sanatorio Otamendi

Ciudad de Buenos Aires, Buenos Aires, 1126, Argentina

Location

Sanatorio Las Lomas

San Isidro, Buenos Aires, 1111, Argentina

Location

Related Publications (2)

• 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.

  PMID: 33174761 BACKGROUND

• Rodriguez-Granillo AM, Mieres J, Fernandez-Pereira C, Sadouet CC, Milei J, Swieszkowski SP, Stutzbach P, Santaera O, Wainer P, Rokos J, Gallardo C, Cristodulo-Cortez R, Perez de la Hoz R, Kastrati A, Rodriguez AE, On Behalf Of Orca Investigators. Randomized Clinical Trial Comparing Bare-Metal Stents Plus Colchicine Versus Drug-Eluting Stents for Preventing Adverse Cardiac Outcomes: Three-Year Follow-Up Results of the ORal Colchicine in Argentina (ORCA) Trial. J Clin Med. 2025 Apr 22;14(9):2871. doi: 10.3390/jcm14092871.

  PMID: 40363904 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Acute Coronary Syndrome; Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Alfredo E Rodriguez, MD, PhD

  Centro de estudios en Cardiologia Intervencionista

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: May 11, 2020
• Study Start: March 12, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 14, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From May 2020 to December 2022
• 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.

Locations

AR (2)