Acute Coronary SyndromePhase 2NCT05472337
Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome
A Phase 2 study testing Colchicine in people with Acute Coronary Syndrome, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
This randomized clinical trial will determine the treatment effect of colchicine (1.5 mg loading dose and 0.5 mg daily thereafter) for 6 weeks on microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 1 Aug 2022to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Adults hospitalized at the Clinical Hospital of the Catholic University for an ACS condition, defined as:
- Presence of chest pain, associated with enzymatic elevation (increase of ultrasensitive troponin above normal value (99th percentile)) with or without electrocardiographic changes.
- Patients undergoing coronary angiography with the intention of angioplasty in the next few days (during the index hospitalization).
- Ability and willingness to provide written informed consent.
Who cannot join
- ST-segment elevation myocardial infarction (undergoing emergency angioplasty therefore not allowing time for the administration and effect of colchicine).
- Severe left main stenosis.
- Advanced heart failure, left ventricular ejection fraction <35%.
- Related to colchicine use: known intolerance, previous use for another condition (e.g., gout), severe liver disease (e.g., severe liver disease).
- Severe liver disease (transaminase elevation 3 times above normal), blood dyscrasia (leukocyte or platelet count lower than normal), glomerular filtration rate (MDRD), use of CYP3A4 or calcineurin inhibitors, active autoimmune disease or the use of chronic anti-inflammatory therapy, concomitant infection, pregnancy or concomitant infection, pregnancy or lactation.
- Any other disease that limits life expectancy to <1 year.
- Medical history of a disorder that could, in the opinion of the treating physician, place the participant at significant risk if they were to participate in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clínico Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8330024
Gonzalo Martinez, Dr., 56 2 23543633, gmartinezr@med.puc.cl
About this study
This randomized clinical trial will determine the treatment effect of colchicine (1.5 mg loading dose and 0.5 mg daily thereafter) for 6 weeks on microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome.
Read the detailed description
Despite significant advances in the treatment of coronary artery disease, acute coronary syndromes (ACS) remain one of the leading causes of mortality and morbidity worldwide. In Chile, it is estimated that cardiovascular disease is responsible for one out of every four deaths Moreover, the consequences of an infarction, i.e., myocardial damage and death, lead to disability, loss of productivity, and economic costs.
Based on the knowledge that ACS occurs as a consequence of the atheroma plaque complication (rupture or erosion) and the consequent thrombosis at that level, current therapy in patients admitted for ACS includes :
(i) acute inhibition of thrombosis by means of antiplatelet and anticoagulant drugs.
ii) Coronary revascularization for severe stenosis by means of coronary angioplasty or bypass surgery.
These therapies have resulted in marked patient benefit, however, in many cases fail to reduce myocardial damage and to achieve adequate myocardial reperfusion.
In fact, in up to 50% of patients with ACS undergoing angioplasty inadequate myocardial reperfusion is observed, despite achieving correct repermeabilization of the coronary artery.
The complication of an atheromatous plaque leading to ACS results from the presence of inflammatory cells, which weaken the vessel wall and promote thrombosis. Both monocytes and neutrophils are key in these phenomena. By intervening in the plaques by means of angioplasty - which includes balloon and implantation of high-pressure stents - both plaque debris, thrombi, and inflammatory cells are released into microcirculation.
This triggers an inflammatory response at this level, which promotes endothelial and tissue edema, myocardial hemorrhage, and direct occlusion of these microvessels.
The result is that even with an adequate recanalization of the epicardial coronary artery (which has the complicated plaque) tissue reperfusion is insufficient, complicating proper recovery of the affected myocardium.
Colchicine is a low-cost, safe, widely available, anti-inflammatory drug, with multiple uses in cardiovascular pathology.
It is recommended in patients with acute pericarditis, including those post-infarction, and has recently been shown to be useful in preventing new cardiovascular events in patients with ACS. Previous studies have shown that during coronary angioplasty in patients with ACS, inflammatory cytokines, neutrophil-derived microparticles, and Neutrophil Extracellular Traps (NETS) are released into the microcirculation.
These are recognized as key agents in the No-Reflow phenomena, by promoting inflammation facilitating thrombosis, and occluding microvessels. Our studies have also shown that the use of Colchicine in a single dose 6 to 24 hours prior to coronary angioplasty results in a dramatic reduction in the release of these inflammatory cytokines and NETs at the time of coronary angioplasty.
It is possible then, that Colchicine is potentially a new strategy to prevent No-Reflow associated with coronary angioplasty in patients with ACS.
In addition, a recent sub-analysis of the Colchicine Cardiovascular Outcomes Trial (COLCOT study, which assessed the use of colchicine vs. placebo in patients with ACS) showed that the use of colchicine mainly benefited those patients who initiated it within the first 3 days of their event and resulted in significantly fewer cardiovascular (CV) episodes (cardiovascular death, infarction, stroke, or emergency hospitalization for angina) at 2-year follow-up, compared with those who initiated it later.
IMR has been shown to have prognostic implications in ACS patients undergoing angioplasty.
The higher the value, the higher the microvascular obstruction, resulting in less myocardial recovery. Index of Microvascular Resistance (IMR) can, in fact, independently predict left ventricular function and infarct size and it is considered a therapeutic target and a relevant measurement in determining the prognosis of patients. Therefore, measurement of IMR before and after angioplasty, makes it possible to determine changes in microcirculation related to the procedure.
Therefore, investigators aim to conduct an open-label randomized controlled trial to evaluate the effects of adding colchicine to standard care among patients with acute coronary syndrome in terms of microvascular obstruction after coronary angioplasty in patients with ACS, as measured by the IMR.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Colchicine
- Keywords
- Colchicine, Myocardial Infarction, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Acute Coronary Syndrome, Myocardial Reperfusion, Anti-Inflammatory Agents
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Oral colchicine (1 mg loading dose followed by 0.5 mg 1 hour later, administered 6 to 24 hours before angioplasty, followed by 0.5 mg (1 comp.) per day for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Subjects allocated to the intervention group will receive colchicine + standard of care for 6 weeks. Receives: Drug: Colchicine |
| Standard of Care - Control | No intervention | Subjects allocated to the control group will receive only standard of care for 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Index of Microcirculatory resistance (IMR) between pre and post-coronary angioplasty.
Invasive assessment of Index of Microvascular Resistance (IMR) before and after angioplasty in both colchicine and control group.
Measured: baseline ( pre-angioplasty) and at the end of the procedure (angioplasty)
Secondary outcomes (4)
Average value of endpoint IMR.
Comparison of IMR obtained post- angioplasty between colchicine and control group
Measured: at the end of the procedure (angioplasty)
Change in cardiac enzyme levels (troponin) before and after angioplasty in both colchicine and control group.
Measurement of Troponin before and after angioplasty in both colchicine and control group
Measured: baseline (pre-angioplasty) and 24 h post-angioplasty
Change in level of inflammatory markers ( Ultra-sensible C-reactive protein and IL-6) at baseline and 6 week follow-up.
Measurement of Ultra-sensible C-reactive protein and Interleukin-6 before and after angioplasty in both colchicine and control group
Measured: baseline (prior to Colchicine administration) and at 6 weeks after discharge
Percent of salvaged myocardium.
Measurement of salvaged myocardium using cardiac magnetic resonance imaging in both colchicine and control group
Measured: baseline (two - four days post-angioplasty and at 6 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Aug 2022
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized comparison between colchicine versus no colchicine in terms of microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Responsible party
- Sponsor
- Investigators
- Gonzalo Martínez, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472337
- Sponsor's protocol ID
- 210507002
- Status last verified
- May 2025
- First submitted
- 23 May 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05472337
- Acronym / sponsor ID
- 210507002
- Conditions
- Acute Coronary Syndrome
- Keywords
- Colchicine, Myocardial Infarction, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Acute Coronary Syndrome, Myocardial Reperfusion, Anti-Inflammatory Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 Jul 2022 (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.
This randomized clinical trial will determine the treatment effect of colchicine (1.5 mg loading dose and 0.5 mg daily thereafter) for 6 weeks on microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome.
Detailed description
Despite significant advances in the treatment of coronary artery disease, acute coronary syndromes (ACS) remain one of the leading causes of mortality and morbidity worldwide. In Chile, it is estimated that cardiovascular disease is responsible for one out of every four deaths Moreover, the consequences of an infarction, i.e., myocardial damage and death, lead to disability, loss of productivity, and economic costs.
Based on the knowledge that ACS occurs as a consequence of the atheroma plaque complication (rupture or erosion) and the consequent thrombosis at that level, current therapy in patients admitted for ACS includes :
(i) acute inhibition of thrombosis by means of antiplatelet and anticoagulant drugs.
ii) Coronary revascularization for severe stenosis by means of coronary angioplasty or bypass surgery.
These therapies have resulted in marked patient benefit, however, in many cases fail to reduce myocardial damage and to achieve adequate myocardial reperfusion.
In fact, in up to 50% of patients with ACS undergoing angioplasty inadequate myocardial reperfusion is observed, despite achieving correct repermeabilization of the coronary artery.
The complication of an atheromatous plaque leading to ACS results from the presence of inflammatory cells, which weaken the vessel wall and promote thrombosis. Both monocytes and neutrophils are key in these phenomena. By intervening in the plaques by means of angioplasty - which includes balloon and implantation of high-pressure stents - both plaque debris, thrombi, and inflammatory cells are released into microcirculation.
This triggers an inflammatory response at this level, which promotes endothelial and tissue edema, myocardial hemorrhage, and direct occlusion of these microvessels.
The result is that even with an adequate recanalization of the epicardial coronary artery (which has the complicated plaque) tissue reperfusion is insufficient, complicating proper recovery of the affected myocardium.
Colchicine is a low-cost, safe, widely available, anti-inflammatory drug, with multiple uses in cardiovascular pathology.
It is recommended in patients with acute pericarditis, including those post-infarction, and has recently been shown to be useful in preventing new cardiovascular events in patients with ACS. Previous studies have shown that during coronary angioplasty in patients with ACS, inflammatory cytokines, neutrophil-derived microparticles, and Neutrophil Extracellular Traps (NETS) are released into the microcirculation.
These are recognized as key agents in the No-Reflow phenomena, by promoting inflammation facilitating thrombosis, and occluding microvessels. Our studies have also shown that the use of Colchicine in a single dose 6 to 24 hours prior to coronary angioplasty results in a dramatic reduction in the release of these inflammatory cytokines and NETs at the time of coronary angioplasty.
It is possible then, that Colchicine is potentially a new strategy to prevent No-Reflow associated with coronary angioplasty in patients with ACS.
In addition, a recent sub-analysis of the Colchicine Cardiovascular Outcomes Trial (COLCOT study, which assessed the use of colchicine vs. placebo in patients with ACS) showed that the use of colchicine mainly benefited those patients who initiated it within the first 3 days of their event and resulted in significantly fewer cardiovascular (CV) episodes (cardiovascular death, infarction, stroke, or emergency hospitalization for angina) at 2-year follow-up, compared with those who initiated it later.
IMR has been shown to have prognostic implications in ACS patients undergoing angioplasty.
The higher the value, the higher the microvascular obstruction, resulting in less myocardial recovery. Index of Microvascular Resistance (IMR) can, in fact, independently predict left ventricular function and infarct size and it is considered a therapeutic target and a relevant measurement in determining the prognosis of patients. Therefore, measurement of IMR before and after angioplasty, makes it possible to determine changes in microcirculation related to the procedure.
Therefore, investigators aim to conduct an open-label randomized controlled trial to evaluate the effects of adding colchicine to standard care among patients with acute coronary syndrome in terms of microvascular obstruction after coronary angioplasty in patients with ACS, as measured by the IMR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized comparison between colchicine versus no colchicine in terms of microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome.
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: ColchicineSubjects allocated to the intervention group will receive colchicine + standard of care for 6 weeks. |
| Standard of Care - Control | No intervention | –Subjects allocated to the control group will receive only standard of care for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Adults hospitalized at the Clinical Hospital of the Catholic University for an ACS condition, defined as:
- Patients undergoing coronary angiography with the intention of angioplasty in the next few days (during the index hospitalization).
- Ability and willingness to provide written informed consent.
Key exclusion criteria (7 listed)
- ST-segment elevation myocardial infarction (undergoing emergency angioplasty therefore not allowing time for the administration and effect of colchicine).
- Severe left main stenosis.
- Advanced heart failure, left ventricular ejection fraction <35%.
- Related to colchicine use: known intolerance, previous use for another condition (e.g., gout), severe liver disease (e.g., severe liver disease).
- Severe liver disease (transaminase elevation 3 times above normal), blood dyscrasia (leukocyte or platelet count lower than normal), glomerular filtration rate (MDRD), use of CYP3A4 or calcineurin inhibitors, active autoimmune disease or the use of chronic anti-inflammatory therapy, concomitant infection, pregnancy or concomitant infection, pregnancy or lactation.
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 |
|---|---|---|
| ColchicineOral colchicine (1 mg loading dose followed by 0.5 mg 1 hour later, administered 6 to 24 hours before angioplasty, followed by 0.5 mg (1 comp.) per day for 6 weeks. | Drug | Colchicine |
Primary outcome
Change in Index of Microcirculatory resistance (IMR) between pre and post-coronary angioplasty.
Time frame: baseline ( pre-angioplasty) and at the end of the procedure (angioplasty)
Invasive assessment of Index of Microvascular Resistance (IMR) before and after angioplasty in both colchicine and control group.
4 secondary outcomes
Average value of endpoint IMR.
Time frame: at the end of the procedure (angioplasty)
Change in cardiac enzyme levels (troponin) before and after angioplasty in both colchicine and control group.
Time frame: baseline (pre-angioplasty) and 24 h post-angioplasty
Change in level of inflammatory markers ( Ultra-sensible C-reactive protein and IL-6) at baseline and 6 week follow-up.
Time frame: baseline (prior to Colchicine administration) and at 6 weeks after discharge
Percent of salvaged myocardium.
Time frame: baseline (two - four days post-angioplasty and at 6 weeks after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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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.
Gonzalo Martínez, MD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine in people with Acute Coronary Syndrome, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gonzalo Martínez, MD (56 223543218, gmartinezr@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Index of Microcirculatory resistance (IMR) between pre and post-coronary angioplasty. (time frame: baseline ( pre-angioplasty) and at the end of the procedure (angioplasty)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2025.