Impact and Time Course of Colchicine Therapy on C-reactive Protein Elevation in Chronic Atrial Fibrillation (AF) and Post AF Ablation
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Change in C-reactive Protein
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Chronic atrial fibrillation, colchicine
Colchicine 0.6 mg PO BID. Subjects not undergoing ablation.
Intervention: Colchicine, 0.6 mg PO BID (Drug)
Chronic atrial fibrillation, placebo
Matching placebo. Subjects not undergoing ablation.
Intervention: Matching placebo (Drug)
Pre-ablation, sinus rhythm, colchicine
Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
Intervention: Colchicine, 0.6 mg PO BID (Drug)
Pre-ablation, sinus rhythm, placebo
Matching placebo. Subjects undergoing ablation.
Intervention: Matching placebo (Drug)
Pre-ablation, AF, colchicine
Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
Intervention: Colchicine, 0.6 mg PO BID (Drug)
Pre-ablation, AF, placebo
Matching placebo. Subjects undergoing ablation.
Intervention: Matching placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Subjects With Atrial Fibrillation(day 28)
- Time Course of C-reactive Protein Levels(baseline, day 3, day 7, day 14, day 28)
Investigators
Joseph L. Blackshear
Principal Investiator
Mayo Clinic