Colchicine in Patients Undergoing Coronary Artery Bypass Grafting After Acute Coronary Syndrome
NCT ID: NCT05726019
Last Updated: 2023-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2022-02-05
2025-02-05
Brief Summary
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Patients will be selected and randomized while still in the emergency room and medication (colchicine 0.5mg every 12 hours or placebo) will be started within 24 hours of randomization, being maintained for 30 days after surgery.
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Detailed Description
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The search for intervention in the inflammatory pathway of atherosclerotic disease in acute coronary syndrome has been the subject of several studies in recent years. In particular, colchicine, a low-cost medication that acts on the inflammatory, atherosclerotic and arrhythmic process, has been the subject of studies in the setting of acute and chronic coronary syndrome and in the perioperative period of coronary artery bypass grafting.
In the elective perioperative context, it presents data that point to a reduction in myocardial injury and post-pericardiotomy syndrome. In addition to the pathophysiological therapeutic potential in postoperative atrial fibrillation, despite not having been demonstrated in a clinical study.
The present study seeks to evaluate the effectiveness of the use of perioperative colchicine with regard to operative complications, in patients with acute coronary syndrome and indication for cardiac post-surgical revascularization.
Patients will be selected and randomized while still in the emergency room and medication (colchicine 0.5mg every 12 hours or placebo) will be started within 24 hours of randomization, being maintained for 30 days after surgery.
The primary outcome will be a composite of postpericardiotomy syndrome, postoperative fibrillation, and periprocedural infarction. Secondary outcomes will be: (1) Death; (2) acute myocardial infarction; (3) stroke; (4) Readmission; (5) Post-pericardiotomy syndrome; (6) Postoperative atrial fibrillation; (7) Periprocedural infarction; (8) Infection; (9) myocardial injury; (10) Length of stay.
Evidences on the use of colchicine in the perioperative scenario of myocardial revascularization in patients with acute coronary syndrome are scarce, and the present study is a pioneer in this evaluation.
Objective documentation of the benefit of colchicine would imply the prescription of the current medication, with great potential for modifying the guidelines of specific medical societies.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Inclusion criteria: Individuals with acute coronary syndrome, with indication for myocardial revascularization surgery, of both genders, aged over 18 years.
Exclusion criteria: Inability to sign the informed consent form; Current use of colchicine; Current use of long-term corticosteroid therapy; Inflammatory bowel disease or chronic diarrhea; Clinically significant non-transient haematological abnormalities; Renal dysfunction, with creatinine greater than 2 times the upper limit of normality; Severe liver disease; Drug addiction or alcoholism; History of clinically significant sensitivity to colchicine.
PREVENTION
NONE
Study Groups
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Colchicine
Oral tablet colchicine 0.5mg, twice a day, will be started within 24 hours after randomization and maintained until 30 days after coronary artery bypass grafting.
Colchicine
Oral tablet colchicine 0.5mg, twice a day, will be started within 24 hours after randomization and maintained until 30 days after coronary artery bypass grafting.
Conventional treatment
The control group will follow conventional treatment guided by current guidelines.
No interventions assigned to this group
Interventions
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Colchicine
Oral tablet colchicine 0.5mg, twice a day, will be started within 24 hours after randomization and maintained until 30 days after coronary artery bypass grafting.
Eligibility Criteria
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Inclusion Criteria
* Patients of both genders, aged over 18 years.
Exclusion Criteria
* Current use of colchicine;
* Current use of long-term corticosteroid therapy
* Inflammatory bowel disease or chronic diarrhea;
* Clinically significant non-transient haematological abnormalities;
* Renal dysfunction, with creatinine greater than 2 times the upper limit of normality;
* Severe liver disease;
* Drug addiction or alcoholism;
* History of clinically significant sensitivity to colchicine.
18 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Locations
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Heart Institute - University of São Paulo
São Paulo, São Paulo, Brazil
Countries
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Facility Contacts
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Other Identifiers
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SDC 5302/21/077
Identifier Type: -
Identifier Source: org_study_id
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