Colchicine and CRP in Atrial Fibrillation and AF Ablation

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Colchicine, 0.6 mg PO BID
* Drug: Matching placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 . Exclusion Criteria: 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. Pregnant and lactating women Lactose intolerance Known sensitivity, allergy, or contraindication to colchicine use

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chronic atrial fibrillation, colchicine<br>Colchicine 0.6 mg PO BID. Subjects not undergoing ablation. | Drug: Colchicine, 0.6 mg PO BID<br>* Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo<br>* Other names: Colcrys;|
| Placebo Comparator: Chronic atrial fibrillation, placebo<br>Matching placebo. Subjects not undergoing ablation. | Drug: Matching placebo<br>* Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug<br>* Other names: placebo;|
| Active Comparator: Pre-ablation, sinus rhythm, colchicine<br>Colchicine 0.6 mg PO BID. Subjects undergoing ablation. | Drug: Colchicine, 0.6 mg PO BID<br>* Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo<br>* Other names: Colcrys;|
| Placebo Comparator: Pre-ablation, sinus rhythm, placebo<br>Matching placebo. Subjects undergoing ablation. | Drug: Matching placebo<br>* Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug<br>* Other names: placebo;|
| Active Comparator: Pre-ablation, AF, colchicine<br>Colchicine 0.6 mg PO BID. Subjects undergoing ablation. | Drug: Colchicine, 0.6 mg PO BID<br>* Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo<br>* Other names: Colcrys;|
| Placebo Comparator: Pre-ablation, AF, placebo<br>Matching placebo. Subjects undergoing ablation. | Drug: Matching placebo<br>* Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in C-reactive Protein | Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay. | baseline, day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | baseline, day 3, day 7, day 14, day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, catheter ablation, colchicine, c reactive protein, CRP