Suspended

END-AFLDLow Dose Colchicine for Reduced Atrial Fibrillation After Open Heart Surgery

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Colchicine

+ Placebo Oral Tablet

Drug
Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

From 18 to 99 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 2017
See protocol details

Summary

Principal SponsorJordan Collaborating Cardiology Group
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 2, 2017

Actual date on which the first participant was enrolled.

Atrial Fibrillation (AF) is a heart condition that can occur after heart surgery, leading to increased risks and complications. Previous studies have used a drug called Colchicine to reduce the occurrence of AF, but the results were not promising due to unpleasant side effects, particularly diarrhea. However, a recent analysis suggested that a lower dose of Colchicine might reduce AF without causing severe side effects. This study aims to test this hypothesis in patients undergoing heart surgery, with the goal of improving care and reducing complications associated with AF. Participants in this study will be randomly assigned to receive either Colchicine or a placebo (a pill with no active ingredients). The Colchicine treatment will start the day before surgery and continue until hospital discharge. The main goal is to measure the occurrence of AF through an Electrocardiogram (EKG), a test that records the heart's electrical activity. The study will also monitor any side effects, particularly those related to the digestive system, to ensure the safety of the lower dose of Colchicine.

Official TitleEffect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients
NCT03015831
Principal SponsorJordan Collaborating Cardiology Group
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

254 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate
Agreed to sign informed consent.
All patients aged 18 years or above undergoing elective cardiac surgery.
Sinus rhythm and no previous AF
8 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Intervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge

Group II

Placebo
Identical tablet (placebo) administered in a similar way as that in the active comparator arm

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Istishari Hospital

Amman, JordanOpen Istishari Hospital in Google Maps
Suspended

Jordan Hospital

Amman, Jordan
Suspended

Khalidi Hospital & Medical Center

Amman, Jordan
Suspended3 Study Centers