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

This study is currently recruiting participants.
Verified November 2017 by Jordan Collaborating Cardiology Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT03015831
First Posted: January 10, 2017
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jordan Collaborating Cardiology Group
  Purpose
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.

Condition Intervention Phase
Atrial Fibrillation Cardiac Surgery Colchicine Adverse Reaction Drug: Colchicine Drug: Placebo Oral Tablet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients

Resource links provided by NLM:


Further study details as provided by Jordan Collaborating Cardiology Group:

Primary Outcome Measures:
  • Atrial fibrillation [ Time Frame: Through study completion, an average of 1 week ]
    AF documented by EKG


Secondary Outcome Measures:
  • Side effects of colchicine [ Time Frame: Through study completion, an average of 1 week ]
    Gastrointestinal side effects


Estimated Enrollment: 1200
Actual Study Start Date: October 2, 2017
Estimated Study Completion Date: May 1, 2020
Estimated Primary Completion Date: April 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015831


Contacts
Contact: Ramzi Tabbalat, MD, FACC 00962795535522 Ramzi_md@yahoo.com

Locations
Jordan
Istishari Hospital Recruiting
Amman, Jordan
Contact: Ayman Hammoudeh, MD, FACC    0096265001000      
Jordan Hospital Recruiting
Amman, Jordan
Contact: Imad Alhaddad, MD    00962795303502    alhaddad63@gmail.com   
Khalidi Hospital & Medical Center Recruiting
Amman, Jordan
Contact: Ramzi Tabbalat, MD, FACC       RAMZI_MD@YAHOO.COM   
Sponsors and Collaborators
Jordan Collaborating Cardiology Group
Investigators
Principal Investigator: Ramzi Tabbalat, MD, FACC JCC Group, Cardiology Department, Khalidi Medical Center, Amman, Jordan
  More Information

Responsible Party: Jordan Collaborating Cardiology Group
ClinicalTrials.gov Identifier: NCT03015831     History of Changes
Other Study ID Numbers: JordanCCG
First Submitted: January 4, 2017
First Posted: January 10, 2017
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jordan Collaborating Cardiology Group:
Atrial fibrillation
Cardiac surgery
Colchicine

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents