NCT04224545

Brief Summary

Postoperative atrial fibrillation (POAF) is a major complication of cardiac surgery, which could lead to high morbidity and mortality, increase duration of hospital stay and increase the cost of treatment. Colchicine possesses both anti-inflammatory and sympatholytic properties, so it has been studied to prevent POAF. The ACC/AHA guidelines for colchicine contain a class IIB recommendation, but the ESC guidelines do not recommend this drug. More researches are needed to focus on reducing of side effects by optimizing the colchicine regimen to reduce the incidence of gastrointestinal side effects. It is believed that further research is needed to investigate the efficacy and safety of colchicine in these conditions. This research is aimed to study the effectiveness of short-term administration of the drug.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2019

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2022

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

December 27, 2019

Last Update Submit

February 19, 2024

Conditions

Colchicine Adverse ReactionAtrial Fibrillation New Onset

Keywords

ColchicinePostoperative atrial fibrillationAnti-inflammatoryCardiac surgerySympatholytic

Outcome Measures

Primary Outcomes (1)

  • Number of participants with postoperative atrial fibrillation.

    POAF detected on continuous ECG monitoring.

    Monitoring is carried out immediately after surgery and will be continued until the end of the 7th postoperative day.

Secondary Outcomes (6)

  • Number of participants with lethal and non-lethal events.

    Participants will be followed for the duration of the postoperative period up to the day of initial discharge from the hospital, an expected average of 7 days.

  • Fluid in the pericardium.

    Diagnostics will be carried out on the 3rd and 5th day after surgery.

  • Fluid in the pleura.

    Diagnostics will be carried out on the 3rd and 5th day after surgery.

  • Acute kidney damage (according to the dynamics of creatinine clearance).

    Diagnostics will be carried out a day before surgery and on the 3rd and 5th day after surgery.

  • Inflammation in blood plasma.

    Diagnostics will be carried out a day before surgery and on the 3rd and 5th day after surgery.

  • +1 more secondary outcomes

Study Arms (2)

Colchicine

EXPERIMENTAL

Colchicine 1 mg day (COLCHICINA LIRCA ® ACARPIA Farmaceutici S.r.l.)

Drug: Colchicine Pill

Placebo

PLACEBO COMPARATOR

Sugar pill

Drug: Placebo

Interventions

Colchicine PillDRUG

Colchicine at a dose of 1 mg a day before surgery, 2, 3, 4, 5 days after surgery.

Also known as: group C
Colchicine
PlaceboDRUG

Placebo started a day before surgery, 2, 3, 4, 5 days after surgery.

Also known as: group P
Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients awaiting elective cardiac surgery (CABG and/or AVR (aortic valve replacement), who are willing and able to give informed consent for participation in the study and who are in sinus rhythm and not taking any antiarrhythmic medication, except beta-adrenergic blocking agents, at the time before surgery.

You may not qualify if:

  • History of persistent or long-term atrial fibrillation/atrial flutter
  • Congenital heart disease, except the bicuspid AV
  • Frequent VE/SVE, AV block 2-3 degrees
  • Use of corticosteroids during the last month
  • Taking any antiarrhythmic drugs, except beta-blockers, within the last 1 month
  • Prior "open" heart surgery
  • Moderate to severe renal failure (creatinine clearance \< 50 ml / min)
  • History of obstructive hepato-biliary disease or other serious hepatic disease
  • Significant mitral valve disease (moderate or severe mitral regurgitation-eg. \> grade II and/or mitral stenosis \& mitral annular calcification).
  • Patient participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Federal Center for Cardiovascular Surgery (Astrakhan)

Astrakhan, Russia

Location

Bakulev National Medical Research Center for Cardiovascular Surgery

Moscow, Russia

Location

Related Publications (3)

  • Shvartz V, Le T, Kryukov Y, Sokolskaya M, Ispiryan A, Khugaeva E, Yurkulieva G, Shvartz E, Petrosyan A, Bockeria L, Bockeria O. Colchicine for Prevention of Atrial Fibrillation after Cardiac Surgery in the Early Postoperative Period. J Clin Med. 2022 Mar 3;11(5):1387. doi: 10.3390/jcm11051387.

    PMID: 35268478RESULT

  • Shvartz V, Le T, Enginoev S, Sokolskaya M, Ispiryan A, Shvartz E, Nudel D, Araslanova N, Petrosyan A, Donakanyan S, Chernov I, Bockeria L, Golukhova E. Colchicine in Cardiac Surgery: The COCS Randomized Clinical Trial. J Cardiovasc Dev Dis. 2022 Oct 20;9(10):363. doi: 10.3390/jcdd9100363.

    PMID: 36286314RESULT

  • Shvartz V.A., Le T.G., Enginoev S.T., Sokolskaya M.A., Ispiryan A.Yu., Shvartz E.N., Nudel D.V., Araslanova N.Kh., Petrosyan A.D., Talibova S.M., Donakanyan S.A., Chernov I.I., Boсkeria L.A., Golukhova E.Z. Association of new markers of systemic inflammation with the risk of developing for the first time postoperative atrial fibrillation when using colchicine in patients undergoing open heart surgery. Annals of arrhythmology. 2023; 20(1): 22-33. (In Russian).

    RESULT

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Vladimir Shvartz

    Bakulev National Medical Research Center for Cardiovascular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized double-blind controlled trial in two groups
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2019

First Posted

January 13, 2020

Study Start

December 23, 2019

Primary Completion

August 15, 2022

Study Completion

August 23, 2022

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

The datasets analyzed during the current study are publicly available. The data is available in the general repository "Open Science Framework" at the link

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
until 2045
Access Criteria
open access
More information

Available IPD Datasets

Individual Participant Data Set Access

Locations

RU(2)