Atrial FibrillationPhase 3COLECTRO-AFNCT05890664
Colchicine After Electrocardioversion for Atrial Fibrillation
A Phase 3 study testing Colchicine in people with Atrial Fibrillation and Cardiac Arrhythmia, run by University Hospital, Basel, Switzerland at 8 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Cardiac Arrhythmia
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 8 sitesSwitzerland
- Study dates
- 14 Apr 2024to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Switzerland8 sites, 8 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Christian Sticherling, Prof., +41 61 265 55 26, christian.sticherling@usb.ch
Philipp Krisai, PD Dr. med., +41 61 265 25 25, Philipp.krisai@usb.ch
- Recruiting
University Hospital Bern
Bern, 3010
Tobias Reichlin, Prof., tobias.reichlin@insel.ch
Tobias Reichlin, Prof.
- Recruiting
Cantonal Hospital Baselland (KSBL)
Bruderholz, Basel-Landschaft, 4101
Christian Maurer, Dr. med., +41 61 436 21 90, christian.maurer@ksbl.ch,
Christian Maurer, Dr. med.
- Recruiting
Lausanne University Hospital
Lausanne, 1011
Etienne Pruvot, Prof. Dr., +41 21 314 11 11, etienne.pruvot@chuv.ch
Etienne Pruvot, Prof. Dr.
- Recruiting
Lucerne Cantonal Hospital
Lucerne, 6000
Ann-Kathrin Gamer, MD, +41 41 205 18 77, annkathrin.gamer@luks.ch
Ann-Kathrin Gamer, MD
- Recruiting
Cantonal Hospital Olten
Olten, 4600
Frank-Peter Stephan, MD, +41 32 627 35 52, frank-peter.stephan@spital.so.ch
Frank-Peter Stephan, MD
- Recruiting
Herzpraxis am Rhein
Rheinfelden, 4310
Flavio Scarcia, MD, +41 61 836 99 88, herzpraxisamrhein@hin.ch
Flavio Scarcia, MD
- Recruiting
Solothurner Spitäler AG
Solothurn, 4500
Frank-Peter Stephan, MD, +41 32 627 35 52, frank-peter.stephan@spital.so.ch
Frank-Peter Stephan
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Cardiac Arrhythmia
- Being tested
- Colchicine, Placebo
- Keywords
- Electrocardioversion, Colchicine
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
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.
PlaceboDrug
Matched placebo. Both the active drug and placebo will look similarly. The route and mode of administration is also similar to the active group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Colchicine |
| Control Group | Placebo comparator | Study participants in the placebo group will receive a matched placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 6 month after electrocardioversion
Secondary outcomes (5)
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.
Measured: 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.
Measured: within 3 month after electrocardioversion
Time to first redo electrocardioversion
Time to first redo electrocardioversion
Measured: 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)
Measured: within 6 month after electrocardioversion
Number of survived participants without an unplanned hospital stay
Number of survived participants without an unplanned hospital stay
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start14 Apr 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blind, placebo-controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Heart Foundation, Fondation Machaon, Switzerland, Genf, Foundation for Cardiovascular Research Basel
- Responsible party
- Sponsor
- Investigators
- Philipp Krisai, PD Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890664
- Sponsor's protocol ID
- 2023-00548, kt21sticherling
- Other IDs
- 2023
- Acronym
- COLECTRO-AF
- Status last verified
- May 2025
- First submitted
- 23 May 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine After Electrocardioversion for Atrial Fibrillation - The COLECTRO-AF Trial
- ClinicalTrials.gov ID
- NCT05890664
- Acronym / sponsor ID
- COLECTRO-AF / 2023-00548, kt21sticherling
- Conditions
- Atrial Fibrillation, Cardiac Arrhythmia
- Keywords
- Electrocardioversion, Colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Heart Foundation, Fondation Machaon, Switzerland, Genf, Foundation for Cardiovascular Research Basel
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double-blind, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: ColchicineStudy 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. |
| Control Group | Placebo comparator | Drug: PlaceboStudy participants in the placebo group will receive a matched placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineColchicine 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. | Drug | Experimental Group |
| PlaceboMatched placebo. Both the active drug and placebo will look similarly. The route and mode of administration is also similar to the active group. | Drug | Control Group |
Primary outcome
Number of atrial fibrillation (AF) recurrence
Time frame: within 6 month after electrocardioversion
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.
5 secondary outcomes
Number of atrial fibrillation (AF) recurrence
Time frame: within 1 month after electrocardioversion
Number of atrial fibrillation (AF) recurrence
Time frame: within 3 month after electrocardioversion
Time to first redo electrocardioversion
Time frame: up to 6 month
Use of antiarrhythmic drugs
Time frame: within 6 month after electrocardioversion
Number of survived participants without an unplanned hospital stay
Time frame: up to 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philipp Krisai, PD Dr. med. principal investigator
University Hospital, Basel, Switzerland
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine in people with Atrial Fibrillation and Cardiac Arrhythmia, run by University Hospital, Basel, Switzerland at 8 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp Krisai, PD Dr. med. (+41 61 265 25 25, Philipp.krisai@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of atrial fibrillation (AF) recurrence (time frame: within 6 month after electrocardioversion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.