Effect of Low Dose ColchiciNe on the InciDence of POAF

NCT03015831 | Terminated Phase 3 DMC

• 1 other identifier: JordanCCG
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 3

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.

Conditions

Atrial Fibrillation; Cardiac Surgery; Colchicine Adverse Reaction

Keywords

Atrial fibrillation; Cardiac surgery; Colchicine

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation

  AF documented by EKG

  Through study completion, an average of 1 week

Secondary Outcomes (1)

• Side effects of colchicine

  Through study completion, an average of 1 week

Study Arms (2)

Colchicine

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

Drug: Colchicine

Placebo Oral Tablet

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Colchicine DRUG

Colchicine will be given to open heart surgery patients

Also known as: Colcrys, Mitigare

Colchicine

Placebo Oral Tablet DRUG

Placebo Oral Tablet will be given to open heart surgery patients according to randomization

Also known as: Placebo

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged 18 years or above undergoing elective cardiac surgery.
• Sinus rhythm and no previous AF
• Agreed to sign informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jordan Collaborating Cardiology Group: lead

Study Sites (3)

Istishari Hospital

Amman, Jordan

Location

Jordan Hospital

Amman, Jordan

Location

Khalidi Hospital & Medical Center

Amman, Jordan

Location

Related Publications (1)

• 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.

  PMID: 32720823 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Ramzi Tabbalat, MD, FACC

  JCC Group, Cardiology Department, Khalidi Medical Center, Amman, Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 10, 2017
• Study Start: October 2, 2017
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

JO (3)