Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients (END-AF)
Primary Purpose
Arrhythmia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Colchicine
Sponsored by
About this trial
This is an interventional prevention trial for Arrhythmia focused on measuring Atrial fibrillation, Colchicine, Cardiac surgery
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Colchicine
No colchicine
Arm Description
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.
In this arm no active medication was administered
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03021343
First Posted
December 22, 2015
Last Updated
December 24, 2017
Sponsor
Jordan Collaborating Cardiology Group
1. Study Identification
Unique Protocol Identification Number
NCT03021343
Brief Title
Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients
Acronym
END-AF
Official Title
Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan Collaborating Cardiology Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
Atrial fibrillation, Colchicine, Cardiac surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colchicine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No colchicine
Arm Type
No Intervention
Arm Description
In this arm no active medication was administered
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
colchicine given as per trial protocol
Primary Outcome Measure Information:
Title
The Number of Participants With Atrial Fibrillation
Description
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
Title
The Number of Participants With Colchicine Side Effects
Description
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramzi A Tabbalat, MD, FACC
Organizational Affiliation
Khalidi Hospital and Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
yes
IPD Sharing Time Frame
2 years from publication date
IPD Sharing Access Criteria
For research purposes after direct contact with principal investigator
Citations:
PubMed Identifier
27502857
Citation
Tabbalat RA, Hamad NM, Alhaddad IA, Hammoudeh A, Akasheh BF, Khader Y. Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial. Am Heart J. 2016 Aug;178:102-7. doi: 10.1016/j.ahj.2016.05.006. Epub 2016 May 17.
Results Reference
result
Learn more about this trial
Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients
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