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.
