Atrial FibrillationPhase 2NCT01755949

Colchicine and CRP in Atrial Fibrillation and AF Ablation

A Phase 2 study testing Colchicine, 0.6 mg PO BID in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Colchicine, 0.6 mg PO BID
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Mar 2013to 6 Dec 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Group 1: Persistent or chronic AF presenting for evaluation in cardiology offices. Diagnosis of AF will be made based on the 12 -lead surface ECG.
Group 2: Paroxysmal AF scheduled to go AF ablation presenting to the electrophysiology laboratory for the procedure in sinus rhythm..
Group 3:Chronic AF scheduled to go clinically indicated AF ablation, and presenting in the electrophysiology laboratory in atrial fibrillation .

Who cannot join

Abnormal liver function with elevated enzymes> 1.5 times the normal.
Abnormal kidney function with glomerular filtration rate < 50 ml/min
Increased levels of creatine kinase or known myopathy
Neutropenia
Known GI disorders
Women of childbearing age who have not had surgical sterilization and are not using oral contraceptives, or who's spouse has not had surgical sterilization will be excluded due to the length of the trial and the possibility that they could become pregnant after entry.

Show all 9Show fewer

Pregnant and lactating women
Lactose intolerance
Known sensitivity, allergy, or contraindication to colchicine use

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic Florida
Jacksonville, Florida, 32224

Other trials in United States

About this study

Official title: Impact and Time Course of Colchicine Therapy on C-reactive Protein Elevation in Chronic Atrial Fibrillation (AF) and Post AF Ablation

Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation

Read the detailed description

Three groups of patients will be randomized to colchicine 0.6 mg PO bis in die (BID) or matching placebo:

Paroxysmal atrial fibrillation, pre-ablation
Persistent atrial fibrillation, pre-ablation
Chronic persistent atrial fibrillation

Conditions: Atrial Fibrillation
Being tested: Colchicine, 0.6 mg PO BID, Matching placebo
Keywords: atrial fibrillation, catheter ablation, colchicine, c reactive protein, CRP
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Colchicine, 0.6 mg PO BIDDrug
Also called Colcrys
Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo
Matching placeboDrug
Also called placebo
Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug

Study groups in NCT01755949
Study group	Role	What they receive
Chronic atrial fibrillation, colchicine	Active comparator	Colchicine 0.6 mg PO BID. Subjects not undergoing ablation. Receives: Drug: Colchicine, 0.6 mg PO BID
Chronic atrial fibrillation, placebo	Placebo comparator	Matching placebo. Subjects not undergoing ablation. Receives: Drug: Matching placebo
Pre-ablation, sinus rhythm, colchicine	Active comparator	Colchicine 0.6 mg PO BID. Subjects undergoing ablation. Receives: Drug: Colchicine, 0.6 mg PO BID
Pre-ablation, sinus rhythm, placebo	Placebo comparator	Matching placebo. Subjects undergoing ablation. Receives: Drug: Matching placebo
Pre-ablation, AF, colchicine	Active comparator	Colchicine 0.6 mg PO BID. Subjects undergoing ablation. Receives: Drug: Colchicine, 0.6 mg PO BID
Pre-ablation, AF, placebo	Placebo comparator	Matching placebo. Subjects undergoing ablation. Receives: Drug: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in C-reactive Protein
Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.
Measured: baseline, day 28

Secondary outcomes (2)

Number of Subjects With Atrial Fibrillation
All subjects will have 12 lead ECG on day 28 to measure the number of subjects with normal sinus rhythm and atrial fibrillation.
Measured: day 28
Time Course of C-reactive Protein Levels
Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.
Measured: baseline, day 3, day 7, day 14, day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 20136 Dec 2016

First posted24 Dec 2012 (estimated)
Study startMar 2013
Primary completion6 Dec 2016
Study completion6 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01755949
Sponsor's protocol ID: 12-001686
Status last verified: Apr 2019
First submitted: 19 Dec 2012
Last updated: 9 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact and Time Course of Colchicine Therapy on C-reactive Protein Elevation in Chronic Atrial Fibrillation (AF) and Post AF Ablation
ClinicalTrials.gov ID: NCT01755949
Acronym / sponsor ID: 12-001686
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation, catheter ablation, colchicine, c reactive protein, CRP
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: Takeda, Detiger Funds
Study start: Mar 2013
Primary completion: 6 Dec 2016 (actual)
Study completion: 6 Dec 2016 (actual)
First posted: 24 Dec 2012 (estimated)
Results: Posted 9 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation

Detailed description

Three groups of patients will be randomized to colchicine 0.6 mg PO bis in die (BID) or matching placebo:

Paroxysmal atrial fibrillation, pre-ablation
Persistent atrial fibrillation, pre-ablation
Chronic persistent atrial fibrillation

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Chronic atrial fibrillation, colchicine	Active comparator	Drug: Colchicine, 0.6 mg PO BIDColchicine 0.6 mg PO BID. Subjects not undergoing ablation.
Chronic atrial fibrillation, placebo	Placebo comparator	Drug: Matching placeboMatching placebo. Subjects not undergoing ablation.
Pre-ablation, sinus rhythm, colchicine	Active comparator	Drug: Colchicine, 0.6 mg PO BIDColchicine 0.6 mg PO BID. Subjects undergoing ablation.
Pre-ablation, sinus rhythm, placebo	Placebo comparator	Drug: Matching placeboMatching placebo. Subjects undergoing ablation.
Pre-ablation, AF, colchicine	Active comparator	Drug: Colchicine, 0.6 mg PO BIDColchicine 0.6 mg PO BID. Subjects undergoing ablation.
Pre-ablation, AF, placebo	Placebo comparator	Drug: Matching placeboMatching placebo. Subjects undergoing ablation.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Group 1: Persistent or chronic AF presenting for evaluation in cardiology offices. Diagnosis of AF will be made based on the 12 -lead surface ECG.
Group 2: Paroxysmal AF scheduled to go AF ablation presenting to the electrophysiology laboratory for the procedure in sinus rhythm..
Group 3:Chronic AF scheduled to go clinically indicated AF ablation, and presenting in the electrophysiology laboratory in atrial fibrillation .

Key exclusion criteria (9 listed)

Abnormal liver function with elevated enzymes> 1.5 times the normal.
Abnormal kidney function with glomerular filtration rate < 50 ml/min
Increased levels of creatine kinase or known myopathy
Neutropenia
Known GI disorders

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 mg PO BIDAlso: ColcrysColchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo	Drug	Chronic atrial fibrillation, colchicine, Pre-ablation, AF, colchicine, Pre-ablation, sinus rhythm, colchicine
Matching placeboAlso: placeboMatching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug	Drug	Chronic atrial fibrillation, placebo, Pre-ablation, AF, placebo, Pre-ablation, sinus rhythm, placebo

Primary outcome

Change in C-reactive Protein
Time frame: baseline, day 28
Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.

2 secondary outcomes

Number of Subjects With Atrial Fibrillation
Time frame: day 28
Time Course of C-reactive Protein Levels
Time frame: baseline, day 3, day 7, day 14, day 28

Results and safety

Results posted to the registry on 9 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chronic Atrial Fibrillation, Colchicine	5	5
Chronic Atrial Fibrillation, Placebo	5	5
Pre-ablation, Sinus Rhythm, Colchicine	4	4
Pre-ablation, Sinus Rhythm, Placebo	5	5
Pre-ablation, AF, Colchicine	4	4
Pre-ablation, AF, Placebo	3	3

Primary outcome: Change in C-reactive Protein

Time frame: baseline, day 28. Mean (Standard Deviation). Unit: ng/mL

Measure	Chronic Atrial Fibrillation, Colchicine n = 5	Chronic Atrial Fibrillation, Placebo n = 5	Pre-ablation, Sinus Rhythm, Colchicine n = 4	Pre-ablation, Sinus Rhythm, Placebo n = 5	Pre-ablation, AF, Colchicine n = 3	Pre-ablation, AF, Placebo n = 3
Baseline	6.4 (7.2)	2.7 (2.9)	2.9 (1.6)	5.9 (5.5)	2.6 (2.7)	2.3 (1.7)
day 28	1.8 (2.0)	2.7 (1.4)	1.0 (0.7)	2.5 (1.7)	1.2 (1.0)	5.2 (5.1)

Chronic Atrial Fibrillation, Colchicine vs Pre-ablation, Sinus Rhythm, Colchicine vs Pre-ablation, AF, Colchicine: p = 0.038, t-test, 2 sided
Chronic Atrial Fibrillation, Placebo vs Pre-ablation, Sinus Rhythm, Placebo vs Pre-ablation, AF, Placebo: p = 0.98, t-test, 2 sided
Chronic Atrial Fibrillation, Colchicine vs Chronic Atrial Fibrillation, Placebo vs Pre-ablation, Sinus Rhythm, Colchicine vs Pre-ablation, Sinus Rhythm, Placebo vs Pre-ablation, AF, Colchicine vs Pre-ablation, AF, Placebo: p = 0.072, t-test, 2 sided

Population analysed: Not all subjects had sample available at all timepoints to measure C-reactive protein levels. Sample was either not collected or insufficient volume to run assay.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Atrial Fibrillation, Colchicine	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Chronic Atrial Fibrillation, Placebo	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Pre-ablation, Sinus Rhythm, Colchicine	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Pre-ablation, Sinus Rhythm, Placebo	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Pre-ablation, AF, Colchicine	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Pre-ablation, AF, Placebo	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Limitations and caveats (from the sponsor): Enrollment was halted in 2015 due to departure of study staff; shortly thereafter Takeda Inc announced it could not renew production of colchicine nor support the study after the end of 2016. Principal investigator elected to terminate enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

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.

Joseph L. Blackshear, MD principal investigator

Consultant in Cardiovascular Diseases

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Colchicine, 0.6 mg PO BID in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.

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 9 May 2019. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in C-reactive Protein (time frame: baseline, day 28). 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 NCT01755949.

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 9 May 2019.