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Colchicine and CRP in Atrial Fibrillation and AF Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01755949
Recruitment Status : Completed
First Posted : December 24, 2012
Results First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborators:
Takeda
Detiger Funds
Information provided by (Responsible Party):
Joseph L. Blackshear, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Colchicine, 0.6 mg PO BID Drug: Matching placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact and Time Course of Colchicine Therapy on C-reactive Protein Elevation in Chronic Atrial Fibrillation (AF) and Post AF Ablation
Study Start Date : March 2013
Actual Primary Completion Date : December 6, 2016
Actual Study Completion Date : December 6, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: placebo




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Subjects With Atrial Fibrillation [ Time Frame: day 28 ]
    All subjects will have 12 lead ECG on day 28 to measure the number of subjects with normal sinus rhythm and atrial fibrillation.

  2. Time Course of C-reactive Protein Levels [ Time Frame: baseline, day 3, day 7, day 14, day 28 ]
    Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755949


Locations
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United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Takeda
Detiger Funds
Investigators
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Principal Investigator: Joseph L. Blackshear, MD Consultant in Cardiovascular Diseases
Additional Information:
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Responsible Party: Joseph L. Blackshear, Principal Investiator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01755949    
Other Study ID Numbers: 12-001686
First Posted: December 24, 2012    Key Record Dates
Results First Posted: May 9, 2019
Last Update Posted: May 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Joseph L. Blackshear, Mayo Clinic:
atrial fibrillation
catheter ablation
colchicine
c reactive protein
CRP
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents