Colchicine treatment for heart attack recovery
Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome
This study tests if colchicine can help people recovering from a heart attack by reducing heart damage and improving their recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago, Santiago Metropolitan) |
| Trial ID | NCT05472337 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of colchicine on coronary reperfusion and infarct size in patients with acute coronary syndrome (ACS). Participants will receive a loading dose of 1.5 mg of colchicine followed by 0.5 mg daily for six weeks. The study aims to address the inadequacies of current treatments that often fail to reduce myocardial damage despite successful revascularization. By targeting inflammation associated with atheroma plaque complications, this trial seeks to improve outcomes for ACS patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are hospitalized for acute coronary syndrome and are scheduled for coronary angioplasty.
Not a fit: Patients experiencing ST-segment elevation myocardial infarction requiring emergency angioplasty or those with severe heart failure or liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance recovery and reduce heart damage in patients suffering from acute coronary syndrome.
How similar studies have performed: While colchicine has been studied in other contexts, this specific application in acute coronary syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Santiago, Santiago Metropolitan
- Hospital Clínico Pontificia Universidad Catolica de Chile — Santiago, Santiago Metropolitan, Chile (Recruiting)
Study contacts
- Principal investigator: Gonzalo Martínez, MD — Pontificia Universidad Catolica de Chile
- Study coordinator: Gonzalo Martínez, MD
- Email: gmartinezr@med.puc.cl
- Phone: 56 223543218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.