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OpenTrials
Completed

NCT Number: NCT01755949

Colchicine and CRP in Atrial Fibrillation and 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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine, 0.6 mg PO BID

Drug

Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo

Other names: Colcrys

Matching Placebo

Drug

Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug

Other names: placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Detiger Funds
  • Takeda

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2012
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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