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Colchicine After Electrocardioversion for Atrial Fibrillation (COLECTRO-AF)

Primary Purpose

Atrial Fibrillation, Cardiac Arrhythmia

Status
Not yet recruiting
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Colchicine
Placebo
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Electrocardioversion, Colchicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel
  • University Hospital Bern
  • Solothurner Spitäler AG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Time to first redo electrocardioversion
Time to first redo electrocardioversion
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)
Number of survived participants without an unplanned hosptial stay
Number of survived participants without an unplanned hosptial stay

Full Information

First Posted
May 23, 2023
Last Updated
June 5, 2023
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss Heart Foundation, Fondation Machaon, Switzerland, Genf, Foundation for Cardiovascular Research Basel
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1. Study Identification

Unique Protocol Identification Number
NCT05890664
Brief Title
Colchicine After Electrocardioversion for Atrial Fibrillation
Acronym
COLECTRO-AF
Official Title
Colchicine After Electrocardioversion for Atrial Fibrillation - The COLECTRO-AF Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss Heart Foundation, Fondation Machaon, Switzerland, Genf, Foundation for Cardiovascular Research Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cardiac Arrhythmia
Keywords
Electrocardioversion, Colchicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, double-blind, placebo-controlled trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
416 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Study participants in the placebo group will receive a matched placebo.
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo. Both the active drug and placebo will look similarly. The route and mode of administration is also similar to the active group.
Primary Outcome Measure Information:
Title
Number of atrial fibrillation (AF) recurrence
Description
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.
Time Frame
within 6 month after electrocardioversion
Secondary Outcome Measure Information:
Title
Number of atrial fibrillation (AF) recurrence
Description
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.
Time Frame
within 1 month after electrocardioversion
Title
Number of atrial fibrillation (AF) recurrence
Description
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.
Time Frame
within 3 month after electrocardioversion
Title
Time to first redo electrocardioversion
Description
Time to first redo electrocardioversion
Time Frame
up to 6 month
Title
Use of antiarrhythmic drugs
Description
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)
Time Frame
within 6 month after electrocardioversion
Title
Number of survived participants without an unplanned hosptial stay
Description
Number of survived participants without an unplanned hosptial stay
Time Frame
up to 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Krisai, PD Dr. med.
Phone
+41 61 265 25 25
Email
Philipp.krisai@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Krisai, PD Dr. med.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Sticherling, Prof.
Phone
+41 61 265 55 26
Email
christian.sticherling@usb.ch
First Name & Middle Initial & Last Name & Degree
Philipp Krisai, PD Dr. med.
Phone
+41 61 265 25 25
Email
Philipp.krisai@usb.ch
First Name & Middle Initial & Last Name & Degree
Christian Sticherling, Prof.
First Name & Middle Initial & Last Name & Degree
Philipp Krisai, PD Dr. med.
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Reichlin, Prof.
Email
tobias.reichlin@insel.ch
First Name & Middle Initial & Last Name & Degree
Tobias Reichlin, Prof.
Facility Name
Solothurner Spitäler AG
City
Solothurn
ZIP/Postal Code
4500
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nisha Arenja, PD Dr. med.
Email
nisha.arenja@spital.so.ch
First Name & Middle Initial & Last Name & Degree
Nisha Arenja

12. IPD Sharing Statement

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Colchicine After Electrocardioversion for Atrial Fibrillation

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