Colchicine After Electrocardioversion for Atrial Fibrillation (COLECTRO-AF)

Colchicine After Electrocardioversion for Atrial Fibrillation - The COLECTRO-AF Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Cardiac Arrhythmia
• Intervention / Treatment: Drug: Colchicine; Drug: Placebo

Detailed Description

Atrial fibrillation is the most common cardiac arrhythmia worldwide and is associated with an increased risk of heart failure, stroke and death. Over the next 40 years the investigators expect another increase in the prevalence of atrial fibrillation with a risk of 1:3 in people over 65 years to develop atrial fibrillation. Electroconversion can occur in patients with atrial fibrillation reestablish sinus rhythm acutely with a controlled electrical shock. Unfortunately it is known however, that there is a short-term recurrence of atrial fibrillation in about 60%. This underlines that our current treatment options are inadequate. There is increasing evidence that inflammation is integral to initiation and maintenance of atrial fibrillation. Therefore, the researchers see inflammation as a possible therapeutic target to reduce the recurrence rate of atrial fibrillation after electroconversion. To test this hypothesis and to help patients, the investigators want to conduct the COLECTRO-AF study.

• Study Type: Interventional
• Enrollment (Estimated): 416
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Philipp Krisai, PD Dr. med.; Phone Number: +41 61 265 25 25; Email: Philipp.krisai@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Philipp Krisai, PD Dr. med.; Phone Number: +41 61 265 25 25; Email: Philipp.krisai@usb.ch
    • Contact: Christian Sticherling, Prof.; Phone Number: +41 61 265 55 26; Email: christian.sticherling@usb.ch
    • Principal Investigator: Christian Sticherling, Prof.
    • Sub-Investigator: Philipp Krisai, PD Dr. med.
  • Bern, Switzerland, 3010
    • Not yet recruiting
    • University Hospital Bern
    • Contact: Tobias Reichlin, Prof.; Email: tobias.reichlin@insel.ch
    • Principal Investigator: Tobias Reichlin, Prof.
  • Solothurn, Switzerland, 4500
    • Not yet recruiting
    • Solothurner Spitäler AG
    • Contact: Nisha Arenja, PD Dr. med.; Email: nisha.arenja@spital.so.ch
    • Principal Investigator: Nisha Arenja

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18 years
• ECG-documented AF prior to ECV
• Successful ECV with conversion of AF to sinus rhythm with persistent sinus rhythm ≥1 hour after ECV
• Ability to give written informed consent

Exclusion Criteria:

• AF persistence after cardioversion or early AF recurrence within 1 hour 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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; 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.
Placebo Comparator: Control Group; Study participants in the placebo group will receive a matched placebo.	Drug: Placebo; Matched placebo. Both the active drug and placebo will look similarly. The route and mode of administration is also similar to the active group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of atrial fibrillation (AF) recurrence	The secondary outcome of AF recurrence within 1 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 1 month after electrocardioversion
Number of atrial fibrillation (AF) recurrence	The secondary outcome of AF recurrence within 3 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 3 month after electrocardioversion
Time to first redo electrocardioversion	Time to first redo electrocardioversion	up to 6 month
Use of antiarrhythmic drugs	Assessment of medication intake by study staff Vaughan-Williams classification class 1 and 3 of antiarrhythmic drugs will be documented (1 = sodium channel blockade, 3 = potassium channel blockade)	within 6 month after electrocardioversion
Number of survived participants without an unplanned hospital stay	Number of survived participants without an unplanned hospital stay	up to 6 month

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss Heart Foundation; Fondation Machaon, Switzerland, Genf; Foundation for Cardiovascular Research Basel
• Investigators: Principal Investigator: Philipp Krisai, PD Dr. med., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Colchicine; Electrocardioversion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: 2023-00548, kt21sticherling

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No