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This study wants to see if the medicine colchicine can help lower inflammation and reduce the chance of developing an irregular heartbeat (atrial fibrillation) after heart bypass surgery. Adults having coronary artery bypass surgery (CABG) can join. Participants will be randomly placed into one of two groups: one group will receive colchicine along with usual care, and the other will receive a placebo (a look-alike capsule with no medicine) along with usual care. Everyone will take a study capsule, and neither the patients nor the study team will know which capsule is being given. Everyone in the study will take study capsule, and neither the patients nor the study team will know who is receiving colchicine or placebo. Blood samples and health information will be collected before surgery; at 24, 48, 72, and 96 hours after surgery; and again at 10 days after surgery or at hospital discharge, whichever comes first. The investigators will look at inflammation marker levels, whether atrial fibrillation happens, and any side effects. This small study will help to generate effect size estimates and safety data that will help plan a larger study in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care and placebo | Placebo Comparator | placebo capsule |
|
| Standard of care and colchicine | Experimental | colchicine capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine (Colcrys®) | Drug | Colchicine dosing is based on actual body weight and renal function (creatinine clearance). Subjects will initiate study medication (placebo or active drug) 5 days prior to surgery and continue therapy for 10 days postoperatively or until hospital discharge, whichever occurs first. For patients weighing ≥70 kg: If CrCl >30 mL/min: Colchicine 0.6 mg twice daily If CrCl <30 mL/min: Colchicine 0.3 mg once daily For patients weighing <70 kg: If CrCl >30 mL/min: Colchicine 0.6 mg once daily If CrCl <30 mL/min: Colchicine 0.3 mg every other day |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammatory markers | markers of inflammation (IL-6, CRP, IL-18, IL-1β, IL-8, and TNF-α) will be measured at predefined time points. Blood samples will be obtained as part of routine clinical care and analyzed using commercially available ELISA assays. | Baseline (pre-surgery), 24, 48, 72, 96 hours post-surgery and 10 days postoperatively or at discharge, whichever occurs first. |
| Rate of post-operative atrial fibrillation (POAF) | Postoperative atrial fibrillation (POAF) incidence will be assessed through daily chart review. | Through discharge (up to 15 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants discontinuing treatment | treatment discontinuation rates due to adverse events will be measured | Through discharge (up to 15 days) |
| Change in Liver Function | Assessed as the impact on clinical biomarkers, i.e., ALT, AST in units per liter. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayesha Ather | Contact | 8592184157 | ayesha.ather@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sibu Saha, MD | University of Kentucky | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucy | Recruiting | Lexington | Kentucky | 40536 | United States |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo dosing is based on actual body weight and renal function (creatinine clearance). Subjects will initiate study medication (placebo or active drug) 5 days prior to surgery and continue therapy for 10 days postoperatively or until hospital discharge, whichever occurs first. For patients weighing ≥70 kg: If CrCl >30 mL/min: Placebo 0.6 mg twice daily If CrCl <30 mL/min: Placebo 0.3 mg once daily For patients weighing <70 kg: If CrCl >30 mL/min: Placebo 0.6 mg once daily If CrCl <30 mL/min: Placebo 0.3 mg every other day |
|
| Baseline and Post operatively (approximately 24 hours) |
| Change in creatinine level | Assessed as the impact on clinical biomarkers, i.e., creatinine level in mg/dl | Baseline through discharge (up to 15 days) |
| Creatine kinase level | Assessed as the impact on clinical biomarkers, creatine kinase (i.e., CK level) in units per liter | Through discharge (up to 15 days) |
| Complete blood count (CBC). | Assessed as the impact on clinical biomarker complete blood count (CBC). | Through discharge (up to 15 days) |