search
Back to results

Colchicine and CRP in Atrial Fibrillation and AF Ablation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Colchicine, 0.6 mg PO BID
Matching placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation, colchicine, c reactive protein, CRP

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Chronic atrial fibrillation, colchicine

Chronic atrial fibrillation, placebo

Pre-ablation, sinus rhythm, colchicine

Pre-ablation, sinus rhythm, placebo

Pre-ablation, AF, colchicine

Pre-ablation, AF, placebo

Arm Description

Colchicine 0.6 mg PO BID. Subjects not undergoing ablation.

Matching placebo. Subjects not undergoing ablation.

Colchicine 0.6 mg PO BID. Subjects undergoing ablation.

Matching placebo. Subjects undergoing ablation.

Colchicine 0.6 mg PO BID. Subjects undergoing ablation.

Matching placebo. Subjects undergoing ablation.

Outcomes

Primary Outcome Measures

Change in C-reactive Protein
Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 19, 2012
Last Updated
April 18, 2019
Sponsor
Mayo Clinic
Collaborators
Takeda, Detiger Funds
search

1. Study Identification

Unique Protocol Identification Number
NCT01755949
Brief Title
Colchicine and CRP in Atrial Fibrillation and AF Ablation
Official Title
Impact and Time Course of Colchicine Therapy on C-reactive Protein Elevation in Chronic Atrial Fibrillation (AF) and Post AF Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 6, 2016 (Actual)
Study Completion Date
December 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Takeda, Detiger Funds

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, catheter ablation, colchicine, c reactive protein, CRP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic atrial fibrillation, colchicine
Arm Type
Active Comparator
Arm Description
Colchicine 0.6 mg PO BID. Subjects not undergoing ablation.
Arm Title
Chronic atrial fibrillation, placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo. Subjects not undergoing ablation.
Arm Title
Pre-ablation, sinus rhythm, colchicine
Arm Type
Active Comparator
Arm Description
Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
Arm Title
Pre-ablation, sinus rhythm, placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo. Subjects undergoing ablation.
Arm Title
Pre-ablation, AF, colchicine
Arm Type
Active Comparator
Arm Description
Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
Arm Title
Pre-ablation, AF, placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo. Subjects undergoing ablation.
Intervention Type
Drug
Intervention Name(s)
Colchicine, 0.6 mg PO BID
Other Intervention Name(s)
Colcrys
Intervention Description
Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Other Intervention Name(s)
placebo
Intervention Description
Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug
Primary Outcome Measure Information:
Title
Change in C-reactive Protein
Description
Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.
Time Frame
baseline, day 28
Secondary Outcome Measure Information:
Title
Number of Subjects With Atrial Fibrillation
Description
All subjects will have 12 lead ECG on day 28 to measure the number of subjects with normal sinus rhythm and atrial fibrillation.
Time Frame
day 28
Title
Time Course of C-reactive Protein Levels
Description
Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.
Time Frame
baseline, day 3, day 7, day 14, day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph L. Blackshear, MD
Organizational Affiliation
Consultant in Cardiovascular Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Colchicine and CRP in Atrial Fibrillation and AF Ablation

We'll reach out to this number within 24 hrs