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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05726019
Other study ID # SDC 5302/21/077
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 5, 2022
Est. completion date February 5, 2025

Study information

Verified date December 2022
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Atherosclerotic disease and its consequences, such as cardiovascular and cerebrovascular disease, are the main causes of morbidity and mortality worldwide, with a rising prevalence as the age pyramid changes with the advancement of society's modernization and medical development. Despite advances, the risk of a new cardiovascular event persists in patients with acute coronary syndrome at around 20% in 3 years. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date February 5, 2025
Est. primary completion date February 5, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with acute coronary syndrome, with indication for myocardial revascularization surgery - Patients 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.

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
Brazil Heart Institute - University of São Paulo São paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite outcome of postpericardiotomy syndrome, postoperative fibrillation, and periprocedural myocardial infarction. 30 days after coronary artery bypass graft
Secondary Death 30 days after coronary artery bypass graft
Secondary Myocardial infarction 30 days after coronary artery bypass graft
Secondary Stroke 30 days after coronary artery bypass graft
Secondary Hospital readmission 30 days after coronary artery bypass graft
Secondary Postpericardiotomy syndrome 30 days after coronary artery bypass graft
Secondary Postoperative fibrillation 30 days after coronary artery bypass graft
Secondary Periprocedural myocardial infarction 30 days after coronary artery bypass graft
Secondary Infection Infection of any kind 30 days after coronary artery bypass graft
Secondary Myocardial injury 30 days after coronary artery bypass graft
Secondary Length of stay 30 days after coronary artery bypass graft
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