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Colchicine and CRP in Atrial Fibrillation and AF Ablation

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: Colchicine, 0.6 mg PO BID (Drug); Matching placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Joseph L. Blackshear, MD, Principal Investigator, Affiliation: Consultant in Cardiovascular Diseases

Overall contact:
Dana G. Kontras, RN, Phone: 904 953-8577, Email: kontras.dana@mayo.edu

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: C-reactive protein

Secondary outcome: Sinus rhythm on ECG

Detailed description: Three groups of patients will be randomized to colchicine 0. 6 mg PO BID or matching placebo: 1. Paroxysmal atrial fibrillation, pre-ablation 2. Persistent atrial fibrillation, pre-ablation 3. Chronic persistent atrial fibrillation

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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: 1. Abnormal liver function with elevated enzymes> 1. 5 times the normal. 2. Abnormal kidney function with glomerular filtration rate < 50 ml/min 3. Increased levels of creatine kinase or known myopathy 4. Neutropenia 5. Known GI disorders 6. 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. 7. Pregnant and lactating women 8. Lactose intolerance

9. Known sensitivity, allergy, or contraindication to colchicine use -

Locations and Contacts

Dana G. Kontras, RN, Phone: 904 953-8577, Email: kontras.dana@mayo.edu

Mayo Clinic Florida, Jacksonville, Florida 32224, United States; Recruiting
Dana g. Kontras, RN, Phone: 904-953-8577, Email: kontras.dana@mayo.edu
Additional Information

Starting date: March 2013
Last updated: March 24, 2015

Page last updated: August 20, 2015

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