Colchicine and CRP in Atrial Fibrillation and AF Ablation

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Colchicine, 0.6 mg PO BID; Drug: Matching placebo

Detailed Description

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

1. Paroxysmal atrial fibrillation, pre-ablation
2. Persistent atrial fibrillation, pre-ablation
3. Chronic persistent atrial fibrillation

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Takeda; Detiger Funds
• Investigators: Principal Investigator: Joseph L. Blackshear, MD, Consultant in Cardiovascular Diseases

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 6, 2016
• Study Completion (Actual): December 6, 2016

Study Registration Dates

• First Submitted: December 19, 2012
• First Submitted That Met QC Criteria: December 19, 2012
• First Posted (Estimate): December 24, 2012

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: atrial fibrillation; catheter ablation; c reactive protein; colchicine; CRP
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: 12-001686

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes