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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Joseph L. Blackshear, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01755949
First received: December 19, 2012
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
Ablation
C Reactive Protein
Drug: Colchicine, 0.6 mg PO BID
Drug: Matching placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • C-reactive protein [ Time Frame: one month ] [ Designated as safety issue: No ]
    Three groups of atrial fibrillation patients, 20 per group, will be randomized to receive colchicine or matching placebo for one month, and have intensive monitoring of c-reactive protein during the month.


Secondary Outcome Measures:
  • Sinus rhythm on ECG [ Time Frame: One month ] [ Designated as safety issue: No ]
    All patients will have 12 lead ECG obtained one month after study enrollment


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chronic atrial fibrillation, active drug
Patient (n=10) with chronic atrial fibrillation who are randomized to colchicine
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
Patients with chronic atrial fibrillation (n=10) who are randomized to placebo.
Drug: Matching placebo
Placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug
Active Comparator: Pre-ablation, sinus rhythm, drug
Patients with paroxysmal atrial fibrillation presenting for catheter ablation in sinus rhythm (n=10) who are randomized to colchicine
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
Patients with paroxysmal atrial fibrillation presenting for catheter ablation in sinus rhythm (n=10) who are randomized to placebo
Drug: Matching placebo
Placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug
Active Comparator: Pre-ablation, atrial fibrillation, drug
Patients presenting for atrial fibrillation catheter ablation in atrial fibrillation (n=10) who are randomized to colchicine
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, atrial fibrillation, placebo
Patients presenting for atrial fibrillation catheter ablation in atrial fibrillation (n=10) who are randomized to placebo
Drug: Matching placebo
Placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug

  Eligibility

Genders Eligible for Study:   Both
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 -
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755949

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

Locations
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Dana g. Kontras, RN    904-953-8577    kontras.dana@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Joseph L. Blackshear, MD Consultant in Cardiovascular Diseases
  More Information

No publications provided

Responsible Party: Joseph L. Blackshear, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01755949     History of Changes
Other Study ID Numbers: 12-001686
Study First Received: December 19, 2012
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
atrial fibrillation
catheter ablation
colchicine
c reactive protein
CRP

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Colchicine
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 15, 2014