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COlchicine in Cardiac Surgery

NCT04224545 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

  • Colchicine Adverse Reaction
  • Atrial Fibrillation New Onset

Interventions

DRUG

Colchicine Pill

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Bakulev Scientific Center of Cardiovascular Surgery

    lead OTHER_GOV

Principal Investigators

  • Vladimir Shvartz · Bakulev National Medical Research Center for Cardiovascular Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2022-08-15
Completion
2022-08-23

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04224545 on ClinicalTrials.gov