Effect of Low Dose ColchiciNe on the InciDence of POAF (END-AFLD)

Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation; Cardiac Surgery; Colchicine Adverse Reaction
• Intervention / Treatment: Drug: Colchicine; Drug: Placebo Oral Tablet

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

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Phase 3

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Istishari Hospital
  • Amman, Jordan
    • Jordan Hospital
  • Amman, Jordan
    • Khalidi Hospital & Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Colchicine; Intervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge	Drug: Colchicine; Colchicine will be given to open heart surgery patients; Other Names: Colcrys, Mitigare
Placebo Comparator: Placebo Oral Tablet; Identical tablet (placebo) administered in a similar way as that in the active comparator arm	Drug: Placebo Oral Tablet; Placebo Oral Tablet will be given to open heart surgery patients according to randomization; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation	AF documented by EKG	Through study completion, an average of 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects of colchicine	Gastrointestinal side effects	Through study completion, an average of 1 week

Collaborators and Investigators

• Sponsor: Jordan Collaborating Cardiology Group
• Investigators: Principal Investigator: Ramzi Tabbalat, MD, FACC, JCC Group, Cardiology Department, Khalidi Medical Center, Amman, Jordan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 7, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Cardiac surgery; Colchicine
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: JordanCCG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No