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

210507002

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.

2022-08-01

2024-04-30

2024-12-30

Recruiting

Early phase I

50

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized comparison between colchicine versus no colchicine in terms of microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-11-18