Acute Coronary Syndrome Clinical Trial
Official title:
Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Clínico Pontificia Universidad Catolica de Chile | Santiago |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile | Fondo Nacional de Desarrollo Científico y Tecnológico, Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | baseline ( pre-angioplasty) and at the end of the procedure (angioplasty) | |
Secondary | Average value of endpoint IMR. | Comparison of IMR obtained post- angioplasty between colchicine and control group | at the end of the procedure (angioplasty) | |
Secondary | 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 | baseline (pre-angioplasty) and 24 h post-angioplasty | |
Secondary | 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 | baseline (prior to Colchicine administration) and at 6 weeks after discharge | |
Secondary | Percent of salvaged myocardium. | Measurement of salvaged myocardium using cardiac magnetic resonance imaging in both colchicine and control group | baseline (two - four days post-angioplasty and at 6 weeks after discharge |
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