Effect of Low Dose ColchiciNe on the InciDence of POAF (END-AFLD)
Primary Purpose
Atrial Fibrillation, Cardiac Surgery, Colchicine Adverse Reaction
Status
Terminated
Phase
Phase 3
Locations
Jordan
Study Type
Interventional
Intervention
Colchicine
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Cardiac surgery, Colchicine
Eligibility Criteria
Inclusion Criteria:
- All patients aged 18 years or above undergoing elective cardiac surgery.
- Sinus rhythm and no previous AF
- Agreed to sign informed consent.
Exclusion Criteria:
- 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 or significant gastrointestinal disease
- Pregnant and lactating women
- Known hypersensitivity to colchicine
- Current treatment with colchicine for any indications
- Emergency surgery
Sites / Locations
- Istishari Hospital
- Jordan Hospital
- Khalidi Hospital & Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Colchicine
Placebo Oral Tablet
Arm Description
Intervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge
Identical tablet (placebo) administered in a similar way as that in the active comparator arm
Outcomes
Primary Outcome Measures
Atrial fibrillation
AF documented by EKG
Secondary Outcome Measures
Side effects of colchicine
Gastrointestinal side effects
Full Information
NCT ID
NCT03015831
First Posted
January 4, 2017
Last Updated
April 29, 2020
Sponsor
Jordan Collaborating Cardiology Group
1. Study Identification
Unique Protocol Identification Number
NCT03015831
Brief Title
Effect of Low Dose ColchiciNe on the InciDence of POAF
Acronym
END-AFLD
Official Title
Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Statistical analysis of interim data showed no advantage of colchicine
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan Collaborating Cardiology Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test 0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.
Detailed Description
AF after cardiac surgery leads to excess mortality and morbidity. Colchicine was used in several studies to lower the incidence AF but the results were generally disappointing. There was no benefit in reducing AF and there was a high incidence of GI side effects especially diarrhea, often leading to stopping the medication. However, a recently published meta-analysis showed that colchicine reduced AF, but again warned of the high incidence of GI side effects. The maintenance dose of colchicine used in these studies was 1 mg daily it is hypothesized that low dose colchicine (0.5 not 1 mg colchicine) might lower AF after cardiac surgery without the prohibitive GI side effects Patients will be randomized to colchicine vs. placebo started the day before surgery and continued until hospital discharge.
The primary efficacy endpoint will be the incidence of AF. The primary safety endpoint will be the GI side effects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cardiac Surgery, Colchicine Adverse Reaction
Keywords
Atrial fibrillation, Cardiac surgery, Colchicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colchicine
Arm Type
Active Comparator
Arm Description
Intervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge
Arm Title
Placebo Oral Tablet
Arm Type
Placebo Comparator
Arm Description
Identical tablet (placebo) administered in a similar way as that in the active comparator arm
Intervention Type
Drug
Intervention Name(s)
Colchicine
Other Intervention Name(s)
Colcrys, Mitigare
Intervention Description
Colchicine will be given to open heart surgery patients
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Placebo
Intervention Description
Placebo Oral Tablet will be given to open heart surgery patients according to randomization
Primary Outcome Measure Information:
Title
Atrial fibrillation
Description
AF documented by EKG
Time Frame
Through study completion, an average of 1 week
Secondary Outcome Measure Information:
Title
Side effects of colchicine
Description
Gastrointestinal side effects
Time Frame
Through study completion, an average of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients aged 18 years or above undergoing elective cardiac surgery.
Sinus rhythm and no previous AF
Agreed to sign informed consent.
Exclusion Criteria:
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 or 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 Tabbalat, MD, FACC
Organizational Affiliation
JCC Group, Cardiology Department, Khalidi Medical Center, Amman, Jordan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istishari Hospital
City
Amman
Country
Jordan
Facility Name
Jordan Hospital
City
Amman
Country
Jordan
Facility Name
Khalidi Hospital & Medical Center
City
Amman
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Our Group's website will share data. Researchgate will share data. Eventual results will be announced to medical community through local presentations, and international congresses and publications.
Citations:
PubMed Identifier
32720823
Citation
Tabbalat RA, Alhaddad I, Hammoudeh A, Khader YS, Khalaf HA, Obaidat M, Barakat J. Effect of Low-dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Low Dose Trial. J Int Med Res. 2020 Jul;48(7):300060520939832. doi: 10.1177/0300060520939832.
Results Reference
derived
Learn more about this trial
Effect of Low Dose ColchiciNe on the InciDence of POAF
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