Colchicine for the Prevention of Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Single-Center, Strategy-Stratified, Randomized, Double-Blind, Placebo-Controlled Trial

NCT07611019 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 202509059MIND
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post-operative atrial fibrillation after coronary artery bypass grafting (CABG)

Conditions

Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG)

Keywords

colchicine; postoperative atrial fibrillation; coronary artery bypass grafting; off-pump surgery; cardiopulmonary bypass; pharmacokinetics; inflammation; neutrophil extracellular traps

Outcome Measures

Primary Outcomes (1)

• Incidence of new-onset atrial fibrillation within 14 days after CABG surgery

  New-onset atrial fibrillation (AF) or atrial flutter (AFL) lasting ≥30 seconds, documented by 12-lead ECG, continuous telemetry monitoring, or 24-hour Holter recording, occurring within 14 days after coronary artery bypass grafting (CABG). Events are adjudicated by blinded cardiologists according to prespecified criteria.

  From the day of surgery through postoperative day 14.

Secondary Outcomes (7)

• Total duration of post-operative atrial fibrillation (POAF)

  From the day of surgery through postoperative day 14.

• Proportion of patients requiring cardioversion for POAF

  From the day of surgery through postoperative day 14.

• Total dose of intravenous amiodarone used for POAF treatment

  From the day of surgery through postoperative day 14.

• Length of stay in the intensive care unit (ICU)

  From the date of surgery until discharge from the intensive care unit or death, whichever occurred first, assessed up to 30 days after surgery.

• Total hospital length of stay

  From hospital admission until hospital discharge or death, whichever occurred first, assessed up to 60 days after surgery.

Study Arms (2)

Colchicine Group

EXPERIMENTAL

Participants will receive colchicine 0.5 mg orally twice daily starting 3 days before surgery and continuing through postoperative day 7 under double-blind conditions. Randomization is stratified by surgical strategy (off-pump CABG versus on-pump CABG).

Drug: Colchicine 0.5 MG oral tablet twice daily

Placebo Group

PLACEBO COMPARATOR

Participants will receive an identically appearing placebo tablet orally twice daily starting 3 days before surgery and continuing through postoperative day 7 under double-blind conditions. Randomization is stratified by surgical strategy (off-pump CABG versus on-pump CABG).

Drug: Placebo Oral Tablet

Interventions

Colchicine 0.5 MG oral tablet twice daily DRUG

Colchicine 0.5 mg administered orally twice daily beginning 3 days before surgery and continuing through postoperative day 7. Temporary interruption or discontinuation is permitted for clinically significant adverse events according to the study safety protocol.

Colchicine Group

Placebo Oral Tablet DRUG

Matching placebo tablet administered orally twice daily beginning 3 days before surgery and continuing through postoperative day 7 under double-blind conditions.

Placebo Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20 years or older scheduled to undergo elective coronary artery bypass grafting (CABG), including either off-pump CABG or on-pump CABG.
• Ability to receive oral study medication before and after surgery.
• Provision of written informed consent before randomization.

You may not qualify if:

• History of atrial fibrillation or atrial flutter before surgery.
• Severe renal impairment (estimated glomerular filtration rate \<30 mL/min/1.73 m²) or chronic dialysis.
• Severe hepatic dysfunction.
• Known hypersensitivity or previous severe adverse reaction to colchicine.
• Pregnancy or breastfeeding.
• Current use of strong CYP3A4 or P-glycoprotein inhibitors that cannot be safely discontinued or substituted.
• Any condition judged by the investigators to interfere with study participation or safety assessment.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (3)

• Imazio M, Brucato A, Ferrazzi P, Rovere ME, Gandino A, Cemin R, Ferrua S, Belli R, Maestroni S, Simon C, Zingarelli E, Barosi A, Sansone F, Patrini D, Vitali E, Trinchero R, Spodick DH, Adler Y; COPPS Investigators. Colchicine reduces postoperative atrial fibrillation: results of the Colchicine for the Prevention of the Postpericardiotomy Syndrome (COPPS) atrial fibrillation substudy. Circulation. 2011 Nov 22;124(21):2290-5. doi: 10.1161/CIRCULATIONAHA.111.026153. Epub 2011 Nov 16.

  PMID: 22090167 RESULT

• Zhao H, Chen Y, Mao M, Yang J, Chang J. A meta-analysis of colchicine in prevention of atrial fibrillation following cardiothoracic surgery or cardiac intervention. J Cardiothorac Surg. 2022 Sep 1;17(1):224. doi: 10.1186/s13019-022-01958-9.

  PMID: 36050741 RESULT

• Wang MX, Deng XL, Mu BY, Cheng YJ, Chen YJ, Wang Q, Huang J, Zhou RW, Huang CB. Effect of colchicine in prevention of pericardial effusion and atrial fibrillation: a meta-analysis. Intern Emerg Med. 2016 Sep;11(6):867-76. doi: 10.1007/s11739-016-1496-5. Epub 2016 Jul 4.

  PMID: 27378573 RESULT

MeSH Terms

Conditions

Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Central Study Contacts

Jeng-Wei Chen, MD

CONTACT

+886-2-2312-3456 ext. 265081; chenjw@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 28, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share