Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A