Colchicine After Electrocardioversion for Atrial Fibrillation

NCT05890664 | Recruiting Phase 3

• 1 other identifier: 2023-00548, kt21sticherling
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to investigate whether a 3 month treatment course of low-dose Colchicine decreases the recurrence of Atrial fibrillation (AF) after electrocardioversion (ECV) in patients with AF.

Conditions

Atrial Fibrillation; Cardiac Arrhythmia

Keywords

Electrocardioversion; Colchicine

Outcome Measures

Primary Outcomes (1)

• Number of atrial fibrillation (AF) recurrence

  The primary outcome of AF recurrence within 6 months will be assessed based on the ECG (electrocardiogram) documentation of any AF. If a patient reports symptoms of AF recurrence in between the study visits, the research staff will obtain an ECG documentation. The outcome will only be valid if AF recurrence is documented by an ECG.

  within 6 month after electrocardioversion

Secondary Outcomes (5)

• Number of atrial fibrillation (AF) recurrence

  within 1 month after electrocardioversion

• Number of atrial fibrillation (AF) recurrence

  within 3 month after electrocardioversion

• Time to first redo electrocardioversion

  up to 6 month

• Use of antiarrhythmic drugs

  within 6 month after electrocardioversion

• Number of survived participants without an unplanned hospital stay

  up to 6 month

Study Arms (2)

Experimental Group

EXPERIMENTAL

Study participants in the active study arm will receive a daily oral dose of 0.5 mg Colchicine for 3 months without a loading dose. The dose is recommended to be taken in the morning. There is no deviation from the usual treatment intake.

Drug: Colchicine

Control Group

PLACEBO COMPARATOR

Study participants in the placebo group will receive a matched placebo.

Drug: Placebo

Interventions

Colchicine DRUG

Colchicine 0.5 mg (oral) once daily for 90 days. The chemical name for colchicine is (S)-N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol\[a\]heptalen-7-yl) acetamide. Colchicine consists of pale yellow scales or powder. It is soluble in water, freely soluble in alcohol, and slightly soluble in ether.

Experimental Group

Placebo DRUG

Matched placebo. Both the active drug and placebo will look similarly. The route and mode of administration is also similar to the active group.

Control Group

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• ECG-documented AF prior to ECV
• Successful ECV with conversion of AF to sinus rhythm with persistent sinus rhythm ≥30 minutes after ECV
• Ability to give written informed consent

You may not qualify if:

• AF persistence after cardioversion or early AF recurrence within 30 minutes after ECV
• Any other rhythm than AF before cardioversion
• Pulmonary vein isolation within 3 months prior to ECV or pulmonary vein isolation planned within 3 months after ECV
• Known intolerance or hypersensitivity to Colchicine
• Any other absolute indication for Colchicine intake
• Intake of a strong inhibitor of CYP3A4 or P-Glycoprotein (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole)
• Serious gastrointestinal disease (severe gastritis or diarrhea)
• Clinically overt hepatic disease
• Severe renal disease (eGFR\< 30ml/min/1.73m2)
• Clinically significant blood dyscrasia (e.g., myelodysplasia)
• Significant immunosuppression (e.g. due to transplantation or rheumatic disease)
• Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control
• Life expectancy \<1 year

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss Heart Foundation: collaborator
• Fondation Machaon, Switzerland, Genf: collaborator
• Foundation for Cardiovascular Research Basel: collaborator

Study Sites (8)

Cantonal Hospital Baselland (KSBL)

Bruderholz, Basel-Landschaft, 4101, Switzerland

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

Lausanne University Hospital

Lausanne, 1011, Switzerland

RECRUITING

Lucerne Cantonal Hospital

Lucerne, 6000, Switzerland

RECRUITING

Cantonal Hospital Olten

Olten, 4600, Switzerland

RECRUITING

Herzpraxis am Rhein

Rheinfelden, 4310, Switzerland

RECRUITING

Solothurner Spitäler AG

Solothurn, 4500, Switzerland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Colchicine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Philipp Krisai, PD Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Krisai, PD Dr. med.

CONTACT

+41 61 265 25 25; Philipp.krisai@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A randomization list will be provided by the Clinical Trial Unit Basel to an unblinded person at the sponsor's site. The unblinded person will allocate the randomization numbers. Patients and research staff involved in patient recruitment, data management, outcome adjudication and data analyses will fully be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double-blind, placebo-controlled trial.

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 6, 2023
• Study Start: April 14, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CH (8)