ArrhythmiaPhase 3END-AFNCT03021343

Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients

A Phase 3 study testing Colchicine in people with Arrhythmia, run by Jordan Collaborating Cardiology Group.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Any age
Conditions the study is for: Arrhythmia
What is being tested?: Colchicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: No sites listed yet
Study dates: Oct 2012to Feb 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

All consecutive adult patients undergoing elective cardiac surgery

Who cannot join

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

Show all 10Show fewer

Pregnant and lactating women
Known hypersensitivity to colchicine
Current treatment with colchicine for any indications
Emergency surgery

About this study

Official title: Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial

Read the 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.

Conditions: Arrhythmia
Being tested: Colchicine
Keywords: Atrial fibrillation, Colchicine, Cardiac surgery
Medical subject headings: Arrhythmias, Cardiac, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ColchicineDrug
colchicine given as per trial protocol

Study groups in NCT03021343
Study group	Role	What they receive
Colchicine	Active comparator	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. Receives: Drug: Colchicine
No colchicine	No intervention	In this arm no active medication was administered

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: From date of randomization until the date of discharge, assessed up to 2 weeks
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.
Measured: From date of randomization until the date of discharge, assessed up to 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Feb 2015

First posted13 Jan 2017 (estimated)
Study startOct 2012
Primary completionJan 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ArrhythmiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03021343
Sponsor's protocol ID: KMC-JCC
Acronym: END-AF
Status last verified: Dec 2017
First submitted: 22 Dec 2015
Last updated: 23 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: yes

Publications

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.
PubMed 27502857

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia

All Arrhythmia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial
ClinicalTrials.gov ID: NCT03021343
Acronym / sponsor ID: END-AF / KMC-JCC
Conditions: Arrhythmia
Keywords: Atrial fibrillation, Colchicine, Cardiac surgery
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Jordan Collaborating Cardiology GroupUniversity, hospital or other
Study start: Oct 2012
Primary completion: Jan 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 13 Jan 2017 (estimated)
Results: Posted 26 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Colchicine	Active comparator	Drug: ColchicineColchicine 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.
No colchicine	No intervention	–In this arm no active medication was administered

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

All consecutive adult patients undergoing elective cardiac surgery

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Colchicinecolchicine given as per trial protocol	Drug	Colchicine

Primary outcome

The Number of Participants With Atrial Fibrillation
Time frame: From date of randomization until the date of discharge, assessed up to 2 weeks
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
Time frame: From date of randomization until the date of discharge, assessed up to 2 weeks
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.

Results and safety

Results posted to the registry on 26 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Colchicine	179	174
No Colchicine	181	174

Primary outcome: The Number of Participants With Atrial Fibrillation

Time frame: From date of randomization until the date of discharge, assessed up to 2 weeks. Count of participants. Unit: Participants

Measure	Colchicine n = 179	No Colchicine n = 181
Value	26	37

Primary outcome: The Number of Participants With Colchicine Side Effects

Time frame: From date of randomization until the date of discharge, assessed up to 2 weeks. Number. Unit: participants

Measure	Colchicine n = 179	No Colchicine n = 181
Value	55	14

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Colchicine	44 of 179 (24.6%)	11 of 179 (6.1%)	Not reported
No Colchicine	10 of 181 (5.5%)	4 of 181 (2.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27502857Tabbalat 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.
Individual participant dataSharing planned: Yes. yes

Related trials for Arrhythmia

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ramzi A Tabbalat, MD, FACC principal investigator

Khalidi Hospital and Medical Center

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Colchicine in people with Arrhythmia, run by Jordan Collaborating Cardiology Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Participants With Atrial Fibrillation (time frame: From date of randomization until the date of discharge, assessed up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03021343, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.