Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome
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|ClinicalTrials.gov Identifier: NCT05472337|
Recruitment Status : Recruiting
First Posted : July 25, 2022
Last Update Posted : September 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Drug: Colchicine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective randomized comparison between colchicine versus no colchicine in terms of microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome.|
|Masking:||None (Open Label)|
|Official Title:||Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome|
|Actual Study Start Date :||August 1, 2022|
|Estimated Primary Completion Date :||October 30, 2023|
|Estimated Study Completion Date :||October 30, 2023|
Subjects allocated to the intervention group will receive colchicine + standard of care for 6 weeks.
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.
No Intervention: Standard of Care - Control
Subjects allocated to the control group will receive only standard of care for 6 weeks.
- Change in Index of Microcirculatory resistance (IMR) between pre and post-coronary angioplasty. [ Time Frame: baseline ( pre-angioplasty) and at the end of the procedure (angioplasty) ]Invasive assessment of Index of Microvascular Resistance (IMR) before and after angioplasty in both colchicine and control group.
- Average value of endpoint IMR. [ Time Frame: at the end of the procedure (angioplasty) ]Comparison of IMR obtained post- angioplasty between colchicine and control group
- Change in cardiac enzyme levels (troponin) before and after angioplasty in both colchicine and control group. [ Time Frame: baseline (pre-angioplasty) and 24 h post-angioplasty ]Measurement of Troponin before and after angioplasty in both colchicine and control group
- Change in level of inflammatory markers ( Ultra-sensible C-reactive protein and IL-6) at baseline and 6 week follow-up. [ Time Frame: baseline (prior to Colchicine administration) and at 6 weeks after discharge ]Measurement of Ultra-sensible C-reactive protein and Interleukin-6 before and after angioplasty in both colchicine and control group
- Percent of salvaged myocardium. [ Time Frame: baseline (two - four days post-angioplasty and at 6 weeks after discharge ]Measurement of salvaged myocardium using cardiac magnetic resonance imaging in both colchicine and control group
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05472337
|Contact: Gonzalo Martínez, MD||56 firstname.lastname@example.org|
|Contact: Maria Paz Orellana||011 56 email@example.com|
|Hospital Clínico Pontificia Universidad Catolica de Chile||Recruiting|
|Santiago, Chile, 8330024|
|Contact: Gonzalo Martinez, Dr. 56 2 23543633 firstname.lastname@example.org|
|Principal Investigator:||Gonzalo Martínez, MD||Pontificia Universidad Catolica de Chile|
|Responsible Party:||Pontificia Universidad Catolica de Chile|
|Other Study ID Numbers:||
|First Posted:||July 25, 2022 Key Record Dates|
|Last Update Posted:||September 9, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Acute Coronary Syndrome
Acute Coronary Syndrome
Molecular Mechanisms of Pharmacological Action