Colchicine For 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 10003662Term: Atrial flutterSystem Organ Class: 10007541 - Cardiac disorders; 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-ES
• Lead Sponsor: Population Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-20
• Last Update Posted: 26 November 2018

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.
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

We will exclude patients who meet any of the following criteria:
1.Patients with a prior history of documented AF;
2.Patients currently taking anti-arrhythmic medication;
3.Patients undergoing minor thoracic interventions/procedures;
4.Patients with contraindications to colchicine;
5.Patients not expected to take oral medications for >24 hours after surgery;
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 age who are not taking an effective form of birth control,
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; OR
12.HIV patients treated with antiretroviral therapy.

Study & Design

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