Phase 2
N=26
Colchicine and CRP in Atrial Fibrillation and AF Ablation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01755949 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Change in C-reactive Protein — 6.4; 2.7; 2.9; 5.9 ng/mL — p=0.038
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Colchicine, 0.6 mg PO BID (Drug); Matching placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in C-reactive Protein |
6.4; 2.7; 2.9; 5.9; 2.6; 2.3 | 0.038 sig |
| SECONDARY Number of Subjects With Atrial Fibrillation |
5; 1; 4; 3; 4; 1 | 0.08 |
| SECONDARY Time Course of C-reactive Protein Levels |
6.4; 2.7; 2.9; 5.9; 2.6; 2.3 | — |
Summary
Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01755949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.