NCT05472337 Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome
| NCT ID | NCT05472337 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pontificia Universidad Catolica de Chile |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2022-08-01 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years. 2. 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. 3. Patients undergoing coronary angiography with the intention of angioplasty in the next few days (during the index hospitalization). 4. Ability and willingness to provide written informed consent. Exclusion Criteria: 1. ST-segment elevation myocardial infarction (undergoing emergency angioplasty therefore not allowing time for the administration and effect of colchicine). 2. Severe left main stenosis. 3. Advanced heart failure, left ventricular ejection fraction \<35%. 4. Related to colchicine use: known intolerance, previous use for another condition (e.g., gout), severe liver disease (e.g., severe liver disease). 5. 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. 6. Any other disease that limits life expectancy to \<1 year. 7. 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.
Contact & Investigator
Gonzalo Martínez, MD
PRINCIPAL INVESTIGATOR
Pontificia Universidad Catolica de Chile
Frequently Asked Questions
Who can join the NCT05472337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05472337 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05472337 currently recruiting?
Yes, NCT05472337 is actively recruiting participants. Contact the research team at gmartinezr@med.puc.cl for enrollment information.
Where is the NCT05472337 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT05472337 clinical trial?
NCT05472337 is sponsored by Pontificia Universidad Catolica de Chile. The principal investigator is Gonzalo Martínez, MD at Pontificia Universidad Catolica de Chile. The trial plans to enroll 50 participants.