The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery

Phase 1

• Conditions: Perioperative atrial fibrillation / atrial flutter after thoracic surgery; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-003836-35-IT
• Lead Sponsor: Population Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2800

Inclusion Criteria

All patients undergoing thoracic surgery with general anesthesia are eligible for the trial if they are =55 years of age at the time of randomization and expected to require at least an overnight hospital
admission after surgery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 980
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1820

Exclusion Criteria

1. patients with a prior history of documented AF;
2. patients currently taking anti-arrhythmic medication other than ß-blockers, calcium channels blockers or digoxin;
3. patients undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies);
4. patients with contraindications to colchicine (i.e., allergy to colchicine, myelodysplastic disorders, or an estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m);
5. patients not expected to take oral medications for >24 hours after surgery (e.g., esophagectomy);
6. patients scheduled for lung transplantation;
7. patients currently taking non-study colchicine before surgery;
8. patients with severe hepatic dysfunction;
9. patients with aplastic anemia;
10. women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding;
11. patients who took within the last 14 days or scheduled to take during the first 10 days after surgery clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole, or itraconazole during the
first 10 days after surgery; OR
12. HIV patients treated with antiretroviral therapy;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified