RecruitingPhase 2NCT05472337

Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome

Sponsor

Pontificia Universidad Catolica de Chile

Enrollment

50 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Coronary Syndrome

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

Min Age: 18 Years

Inclusion Criteria5

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.

Exclusion Criteria7

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.

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Interventions

DRUGColchicine

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.