Phase 3
Completed N=100
Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study
Source: ClinicalTrials.gov NCT01985425 ↗Enrolled (actual)
100
Serious AEs
6.0%
Results posted
Jan 2017
Primary outcomePrimary: Clinically Significant Atrial Fibrillation — 5; 6 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this pilot study is to determine the feasibility of comparing colchicine to placebo for the prevention of new onset atrial fibrillation in patients undergoing general thoracic surgery and establish the foundation for a large, multi-centre, clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinically Significant Atrial Fibrillation |
5; 6 | — |
| SECONDARY Death |
0; 0 | — |
| SECONDARY New Onset Atrial Flutter |
0; 1 | — |
| SECONDARY Myocardial Injury After Non-Cardiac Surgery (MINS) |
10; 12 | — |
| SECONDARY Stroke |
0; 0 | — |
| SECONDARY Transient Ischemic Attack (TIA) |
0; 0 | — |
| SECONDARY Post-operative Infection |
6; 8 | — |
Eligibility Criteria
Inclusion Criteria
- All patients ≥55 years of age undergoing intra-thoracic surgery for a resection of tumor in lung.
Exclusion Criteria
- In AF prior to surgery*,
- Undergoing minor thoracic interventions/ procedures (i.e., chest tube insertion, needle pleural/lung biopsies, or minor chest-wall surgeries), or
- With contraindications to colchicine (i.e., allergy, or myelodysplastic disorders or estimated glomerular filtration rate [e-GFR] <30 mL/min/1.73m)
- Clarification: Patients with history of AF who are in sinus rhythm during enrollment will be eligible for recruitment. Patients who have no history of AF and are found to be in AF at the time of enrollment will not be eligible.
Data sourced from ClinicalTrials.gov (NCT01985425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.