A Phase 3 interventional study of Colchicine in Arrhythmia, sponsored by Jordan Collaborating Cardiology Group. Completed. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Jordan Collaborating Cardiology Group · Phase 3, Interventional, and Prevention
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
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 360 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Jordan Collaborating Cardiology Group is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Colchicine
In this arm no active medication was administered
colchicine given as per trial protocol
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
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
| Milestone | Colchicine | No Colchicine |
|---|---|---|
| Started | 179 | 181 |
| Completed | 174 | 174 |
| Not completed | 5 | 7 |
The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant
| Participants | Colchicine | No Colchicine |
|---|---|---|
| The Number of Participants With Atrial Fibrillation | 26 | 37 |
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.
| participants | Colchicine | No Colchicine |
|---|---|---|
| The Number of Participants With Colchicine Side Effects | 55 | 14 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Colchicine | — | 44/179 (24.6%) | 11/179 (6.1%) |
| No Colchicine | — | 10/181 (5.5%) | 4/181 (2.2%) |
| Event | Colchicine | No Colchicine |
|---|---|---|
| DiarrheaGastrointestinal disorders | 44/179 | 10/181 |
| Event | Colchicine | No Colchicine |
|---|---|---|
| AnorexiaGastrointestinal disorders | 11/179 | 4/181 |
| Age, Continuous(years) | Colchicine | No Colchicine | Total |
|---|---|---|---|
| Mean | 60.8 (20 to 82) | 60.5 (23 to 98) | 60.6 (20 to 98) |
| Sex: Female, Male(Participants) | Colchicine | No Colchicine | Total |
|---|---|---|---|
| Female | 38 | 38 | 76 |
| Male | 141 | 143 | 284 |
| Race and Ethnicity Not Collected(Participants) | Colchicine | No Colchicine | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
No study locations are listed for this record.
Plan to share: Yes — yes
Supporting information: Study protocol
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Jordan Collaborating Cardiology Group