Arrhythmia
Conditions
Keywords
Atrial fibrillation, Colchicine, Cardiac surgery
Brief summary
This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not
Detailed description
Atrial fibrillation (AF) is the most common arrhythmia in patients undergoing cardiac surgery and is estimated to occur in 26% of all cardiac surgery patients. It can lead to increase morbidity, mainly due to hemodynamic instability and thromboembolic complications, and to increased hospital stay with its associated higher health care cost. Previous studies have demonstrated that increased inflammation may precede AF and, therefore, interventions that reduce the inflammatory process may help reduce the incidence of AF. Colchicine has potent anti-inflammatory properties and may therefore be capable of reducing the incidence of AF. This study aims to determine whether the administration of colchicine starting the day before cardiac surgery and continuing until discharge may lead to reduction in post-operative AF.
Interventions
DRUGColchicine
colchicine given as per trial protocol
Sponsors
Jordan Collaborating Cardiology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All consecutive adult patients undergoing elective cardiac surgery
Exclusion criteria
* Documented history of AF or supraventricular arrhythmia or, absence of sinus rhythm on hospital admission * Known severe liver disease or current transaminases \>1.5 times the upper normal limit * Current serum creatinine \>2.5 mg/dl * Known myopathy or elevated baseline preoperative creatine kinase * Known blood dyscrasias * Significant gastrointestinal disease * Pregnant and lactating women * Known hypersensitivity to colchicine * Current treatment with colchicine for any indications * Emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Atrial Fibrillation | From date of randomization until the date of discharge, assessed up to 2 weeks | The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant |
| The Number of Participants With Colchicine Side Effects | From date of randomization until the date of discharge, assessed up to 2 weeks | The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Colchicine Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing \<70 kg or intolerant to the full dose.
Colchicine: colchicine given as per trial protocol | 179 |
| No Colchicine In this arm no active medication was administered | 181 |
| Total | 360 |
Baseline characteristics
| Characteristic | Colchicine | No Colchicine | Total |
|---|---|---|---|
| Age, Continuous | 60.8 years | 60.5 years | 60.6 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 38 Participants | 38 Participants | 76 Participants |
| Sex: Female, Male Male | 141 Participants | 143 Participants | 284 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 179 | 4 / 181 |
| serious Total, serious adverse events | 44 / 179 | 10 / 181 |
Outcome results
Primary
The Number of Participants With Atrial Fibrillation
The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant
Time frame: From date of randomization until the date of discharge, assessed up to 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Colchicine | The Number of Participants With Atrial Fibrillation | 26 Participants |
| No Colchicine | The Number of Participants With Atrial Fibrillation | 37 Participants |
Primary
The Number of Participants With Colchicine Side Effects
The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.
Time frame: From date of randomization until the date of discharge, assessed up to 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Colchicine | The Number of Participants With Colchicine Side Effects | 55 participants |
| No Colchicine | The Number of Participants With Colchicine Side Effects | 14 participants |