Atrial FibrillationPhase 3NCT04160117
Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI Pilot)
A Phase 3 study testing Colchicine 0.6 mg in people with Atrial Fibrillation and Recurrence, run by Population Health Research Institute at 1 site in Canada.
Trial summary
Recurrence is a common problem after catheter ablation for atrial fibrillation, affecting at least one out of three patients. Inflammation due to the procedure may contribute to pulmonary vein reconnection and, thus, failure of catheter ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Recurrence
- What is being tested?
- Colchicine 0.6 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2020to 30 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Symptomatic atrial fibrillation and planned catheter-guided first or repeat ablation (pulmonary vein isolation) for atrial fibrillation (radiofrequency or cryoablation energy; concomitant ablation of the cavotricuspid isthmus and other lesions left at the discretion of the treating physician)
- Written informed consent
Who cannot join
- Ablation for left atrial tachycardia or isthmus-dependent atrial flutter only (i.e. without pulmonary vein isolation)
- Administration of a strong inhibitor of CYP3A4 or p-gp (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole)
- Known hypersensitivity to colchicine
- Serious gastrointestinal disease (severe gastritis or diarrhea)
- Clinically overt hepatic disease
- Severe renal disease (eGFR< 30ml/min/1.73m2)
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- Clinically significant blood dyscrasia (e.g., myelodysplasia)
- Absolute indication for or ongoing treatment with colchicine
- Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences Corporation - Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
About this study
Official title: Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI): A Pilot Study
Recurrence is a common problem after catheter ablation for atrial fibrillation, affecting at least one out of three patients. Inflammation due to the procedure may contribute to pulmonary vein reconnection and, thus, failure of catheter ablation.
This pilot study will assess whether a randomized, placebo-controlled, double-blind trial investigating a 10-day treatment with colchicine, a potent anti-inflammatory drug, to improve patient relevant outcomes after catheter ablation for atrial fibrillation is feasible.
- Conditions
- Atrial Fibrillation, Recurrence
- Being tested
- Colchicine 0.6 mg, Matching placebo
- Medical subject headings
- Atrial Fibrillation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.6 mgDrug
p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
Matching placeboDrug
p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Colchicine 0.6 mg p.o. twice daily for 10 days after catheter ablation for atrial fibrillation Receives: Drug: Colchicine 0.6 mg |
| Control | Placebo comparator | Matching placebo p.o. twice daily for 10 days after catheter ablation for atrial fibrillation Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average monthly enrollment rate
Average number of patients enrolled per month
Measured: Through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)
Compliance with study treatment
Number of provided capsules taken (measured as a proportion of 20 capsules)
Measured: From randomization until 10 days after catheter ablation
Rate of complete follow-up at 6 months
This will describe the rate of patients for whom the 6-month follow visit can be completed
Measured: From inception until completion of the study
Secondary outcomes (6)
Rate of non-infectious diarrhea
Three or more loose stools per day, in absence of an overt infectious cause
Measured: From randomization until 10 days after catheter ablation
Rate of signs and symptoms of pericarditis
Evidence of new or worsening pericardial effusion on echocardiogram, friction rub on auscultation or pleuritic chest pain
Measured: From randomization until 10 days after catheter ablation
Recurrence of atrial fibrillation within the first 2 weeks after catheter ablation
Any episode of atrial fibrillation lasting > 30 seconds within 2 weeks after catheter ablation for atrial fibrillation. Atrial flutter or other forms of atrial tachycardia are included in this definition
Measured: From randomization until 2 weeks after catheter ablation for atrial fibrillation
Recurrence of atrial fibrillation between 10-15 weeks after catheter ablation
Any episode of atrial fibrillation lasting > 30 seconds between 10-15 weeks after catheter ablation for atrial fibrillation. Atrial flutter or other forms of atrial tachycardia are included in this definition
Measured: Between week 10 and 15 after catheter ablation for atrial fibrillation
Rate of patients with composite clinical endpoint
Emergency department visit: Patient seeking medical attention at any emergency department or Hospitalization for cardiovascular cause: Minimum of one overnight stay in hospital for cardiovascular reason (e.g. recurrence of atrial fibrillation, atrial flutter, atrial tachycardia; hypotension; hypertension; heart failure; myocardial infarction; bleeding, stroke etc.) or Cardioversion: Pharmacological or electrical attempt of or restoring sinus rhythm, irrespective of success of the procedure or Repeat ablation for atrial fibrillation, atrial flutter or left atrial tachycardia: Catheter-guided pulmonary vein isolation, or ablation of cavotricuspid isthmus, or ablation for other left atrial tachycardia (e.g. macro-reentrant tachycardia, focal tachycardia) after the index procedure
Measured: Through study completion (estimated to be up to 24 months)
Rate of all-cause mortality
This will describe the rate of all-cause mortality during the course of the study.
Measured: Through study completion (estimated to be up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start14 Jan 2020
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Benz, MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160117
- Sponsor's protocol ID
- IMPROVE-PVI pilot
- Status last verified
- Sep 2024
- First submitted
- 7 Nov 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benz AP, Amit G, Connolly SJ, Singh J, Acosta-Velez JG, Conen D, Deif B, Divakaramenon S, McIntyre WF, Mtwesi V, Roberts JD, Wong JA, Zhao R, Healey JS; IMPROVE-PVI Investigators. Colchicine to Prevent Atrial Fibrillation Recurrence After Catheter Ablation: A Randomized, Placebo-Controlled Trial. Circ Arrhythm Electrophysiol. 2024 Jan;17(1):e01238. doi: 10.1161/CIRCEP.123.012387. Epub 2023 Dec 21.
PubMed 38126206
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI): A Pilot Study
- ClinicalTrials.gov ID
- NCT04160117
- Acronym / sponsor ID
- IMPROVE-PVI pilot
- Conditions
- Atrial Fibrillation, Recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 12 Nov 2019 (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.
Recurrence is a common problem after catheter ablation for atrial fibrillation, affecting at least one out of three patients. Inflammation due to the procedure may contribute to pulmonary vein reconnection and, thus, failure of catheter ablation.
This pilot study will assess whether a randomized, placebo-controlled, double-blind trial investigating a 10-day treatment with colchicine, a potent anti-inflammatory drug, to improve patient relevant outcomes after catheter ablation for atrial fibrillation is feasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Colchicine 0.6 mgColchicine 0.6 mg p.o. twice daily for 10 days after catheter ablation for atrial fibrillation |
| Control | Placebo comparator | Drug: Matching placeboMatching placebo p.o. twice daily for 10 days after catheter ablation for atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Symptomatic atrial fibrillation and planned catheter-guided first or repeat ablation (pulmonary vein isolation) for atrial fibrillation (radiofrequency or cryoablation energy; concomitant ablation of the cavotricuspid isthmus and other lesions left at the discretion of the treating physician)
- Written informed consent
Key exclusion criteria (9 listed)
- Ablation for left atrial tachycardia or isthmus-dependent atrial flutter only (i.e. without pulmonary vein isolation)
- Administration of a strong inhibitor of CYP3A4 or p-gp (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole)
- Known hypersensitivity to colchicine
- Serious gastrointestinal disease (severe gastritis or diarrhea)
- Clinically overt hepatic disease
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 |
|---|---|---|
| Colchicine 0.6 mgp.o. twice daily for 10 days after catheter ablation for atrial fibrillation | Drug | Intervention |
| Matching placebop.o. twice daily for 10 days after catheter ablation for atrial fibrillation | Drug | Control |
Primary outcome
Average monthly enrollment rate
Time frame: Through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)
Average number of patients enrolled per month
Compliance with study treatment
Time frame: From randomization until 10 days after catheter ablation
Number of provided capsules taken (measured as a proportion of 20 capsules)
Rate of complete follow-up at 6 months
Time frame: From inception until completion of the study
This will describe the rate of patients for whom the 6-month follow visit can be completed
6 secondary outcomes
Rate of non-infectious diarrhea
Time frame: From randomization until 10 days after catheter ablation
Rate of signs and symptoms of pericarditis
Time frame: From randomization until 10 days after catheter ablation
Recurrence of atrial fibrillation within the first 2 weeks after catheter ablation
Time frame: From randomization until 2 weeks after catheter ablation for atrial fibrillation
Recurrence of atrial fibrillation between 10-15 weeks after catheter ablation
Time frame: Between week 10 and 15 after catheter ablation for atrial fibrillation
Rate of patients with composite clinical endpoint
Time frame: Through study completion (estimated to be up to 24 months)
Rate of all-cause mortality
Time frame: Through study completion (estimated to be up to 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 38126206Benz AP, Amit G, Connolly SJ, Singh J, Acosta-Velez JG, Conen D, Deif B, Divakaramenon S, McIntyre WF, Mtwesi V, Roberts JD, Wong JA, Zhao R, Healey JS; IMPROVE-PVI Investigators. Colchicine to Prevent Atrial Fibrillation Recurrence After Catheter Ablation: A Randomized, Placebo-Controlled Trial. Circ Arrhythm Electrophysiol. 2024 Jan;17(1):e01238. doi: 10.1161/CIRCEP.123.012387. Epub 2023 Dec 21.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alexander Benz, MD principal investigator
Population Health Research Institute
1 site 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 0.6 mg in people with Atrial Fibrillation and Recurrence, run by Population Health Research Institute at 1 site in Canada.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average monthly enrollment rate (time frame: Through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04160117, which also lists 1 linked publication.
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 19 Sep 2024.