Coronary Artery DiseasePhase 4ORCANCT04382443
Oral Colchicine in Argentina to Prevent Restenosis
A Phase 4 study testing Colchicine in people with Coronary Artery Disease and Restenosis of Coronary Artery Stent, run by Centro de estudios en Cardiologia Intervencionista at 2 sites in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Coronary Artery Disease, Restenosis of Coronary Artery Stent, Atherosclerosis
- What is being tested?
- Colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 2 sitesArgentina
- Study dates
- 12 Mar 2020to 30 Apr 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites
Sanatorio Otamendi
Ciudad de Buenos Aires, Buenos Aires, 1126
Sanatorio Las Lomas
San Isidro, Buenos Aires, 1111
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Restenosis of Coronary Artery Stent, Atherosclerosis, Acute Coronary Syndrome
- Being tested
- Colchicine
- Keywords
- restenosis, atherosclerosis, acute coronary syndrome, percutaneous coronary intervention, colchicine, inflammation
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Acute Coronary Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called BMS+Colchicine
At the moment of BMS implantation intervention will mean that this group will receive colchicine as described.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 365 days
Secondary outcomes (1)
Target lesion failure
Target lesion failure (TLF): TLF was defined as cardiac death, MI and ischemic driving revascularization (TLR) of initially treated lesion.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start12 Mar 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de estudios en Cardiologia Intervencionista
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo E Rodriguez, Centro de estudios en Cardiologia Intervencionista
- Investigators
- Alfredo E Rodriguez, MD, PhD, Study chair, Centro de estudios en Cardiologia Intervencionista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382443
- Sponsor's protocol ID
- CECI-03
- Acronym
- ORCA
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2020
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All researchers that want to work with the database must sign a confidentiality form and all legal documents applicable for the time being.
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.
PubMed 33174761Rodriguez-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.
PubMed 40363904
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Colchicine in Argentina (ORCA Trial) for the Prevention of Adverse Events After Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT04382443
- Acronym / sponsor ID
- ORCA / CECI-03
- Conditions
- Coronary Artery Disease, Restenosis of Coronary Artery Stent, Atherosclerosis, Acute Coronary Syndrome
- Keywords
- restenosis, atherosclerosis, acute coronary syndrome, percutaneous coronary intervention, colchicine, inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Centro de estudios en Cardiologia IntervencionistaUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Colchicine +BMS implantation | Experimental | Drug: ColchicineThis 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 |
| 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical and angiographic
- 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.
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineAlso: BMS+ColchicineAt the moment of BMS implantation intervention will mean that this group will receive colchicine as described. | Drug | Oral Colchicine +BMS implantation |
Primary outcome
MACE
Time frame: 365 days
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.
1 secondary outcome
Target lesion failure
Time frame: 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Results publication: PubMed 33174761Correa-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.
- Derived from this study: PubMed 40363904Rodriguez-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.
- Individual participant dataSharing planned: Yes. All researchers that want to work with the database must sign a confidentiality form and all legal documents applicable for the time being.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo E Rodriguez, MD, PhD study chair
Centro de estudios en Cardiologia Intervencionista
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine in people with Coronary Artery Disease and Restenosis of Coronary Artery Stent, run by Centro de estudios en Cardiologia Intervencionista at 2 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04382443, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.