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Colchicine in Atrial Fibrillation to Prevent Stroke (CIAFS-1)

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ClinicalTrials.gov Identifier: NCT02282098
Recruitment Status : Recruiting
First Posted : November 4, 2014
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Noel Chan, Population Health Research Institute

Brief Summary:
The purpose of this study is to determine the feasibility of performing a randomized controlled trial to investigate the efficacy of an anti-inflammatory drug, colchicine, at reducing well validated markers of thrombosis (D-dimer) and inflammation (hs-CRP).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Drug: Colchicine Drug: Placebo Phase 3

Detailed Description:
Atrial fibrillation (AF), the most common cardiac arrhythmia (with a global burden of 33.5 million affected patients in 2010), is responsible for about 20% of ischemic stroke, a major cause of morbidity and mortality. Anticoagulants are very effective in reducing the risk of stroke in AF but on average 10-15% of treated patients still experience a stroke over a 10-year period and in selected elderly populations the risk is even higher. We hypothesize that thrombosis mediated by inflammation might be responsible for the residual risk of stroke, despite anticoagulant therapy and that targeting inflammation has the potential to reduce thrombosis and the risk of stroke in anticoagulated patients with AF.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Targeting Inflammation in Atrial Fibrillation to Prevent Ischemic Stroke: A Feasibility Study Evaluating the Effect of Colchicine on D-dimer and Hs-CRP in Anticoagulated Patients With Atrial Fibrillation
Study Start Date : November 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: Active Colchicine
The intervention group will receive colchicine 0.6 mg twice daily orally for 3 months
Drug: Colchicine
Colchicine 0.6mg twice daily
Other Name: pms-Colchicine

Placebo Comparator: Placebo Colchicine
The control group will receive colchicine placebo 0.6mg twice daily orally for 3 months.
Drug: Placebo
Placebo Colchicine
Other Name: Placebo Capsule




Primary Outcome Measures :
  1. Recruitment rates [ Time Frame: Randomization to Month 3 ]
    Number of eligible patients successfully randomized into study per year of study.

  2. Drop-out rates [ Time Frame: Randomization to Month 3 ]
    Proportion of participants withdrawing from study for any reason


Secondary Outcome Measures :
  1. D-dimer [ Time Frame: Randomization to Month 3 ]
    Mean D-dimer level at baseline and Month 3 for each arm

  2. hs-CRP [ Time Frame: Randomization to Month 3 ]
    Mean level of hs-CRP at baseline and month 3 for each arm

  3. Proportion of patients with a clinically significant adverse event [ Time Frame: Randomization to Month 3 ]
    Proportion of patients with side effects such as diarrhoea, myopathy requiring drug cessation

  4. Drug adherence [ Time Frame: Randomization to Month 3 ]
    Proportion of missing pill to dispensed pill at 6 weeks and month 3



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with atrial fibrillation who has been receiving chronic anticoagulation for at least 3 months.

Exclusion Criteria:

  • Contraindications to colchicine such as allergy/hypersensitivity,
  • Receiving colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, anti-neoplastic, Interleukin 1-1b antagonist, Tumor necrosis factor-alpha inhibitor),
  • Receiving food or co-medications such as strong-moderate cytochrome P450 3A4 inhibitors that will result in elevated plasma level of colchicine,
  • Inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infection,
  • Severe renal (eGFR< 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST > 2x Upper limit of normal),
  • Moderate or severe cytopenias (platelet < 100, neutrophil count < 1.5) or existing blood dyscrasia (e.g., myelodysplasia)
  • Pregnant or lactating woman or woman of child bearing age no protected by reliable contraception.

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): NCT02282098


Contacts
Contact: Debi Sloane 905-527-4322 ext 40408 debi.sloane@phri.ca
Contact: Alexandra Sabev 905-527-4322 ext 40663 Alexandra.Sabev@phri.ca

Locations
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Alexandra Sabev, CCRA    905-527-4322 ext 40663    alexandra.sabev@phri.ca   
Principal Investigator: John Eikelboom, MD         
Sponsors and Collaborators
Population Health Research Institute
Investigators
Principal Investigator: Noel Chan, MD Population Health Research Institute
Principal Investigator: John Eikelboom, MD Population Health Research Institute

Responsible Party: Noel Chan, PI, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02282098     History of Changes
Other Study ID Numbers: NIF-14350
NIF-14350 ( Other Grant/Funding Number: Hamilton Health Science New Investigator Fund )
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by Noel Chan, Population Health Research Institute:
Atrial fibrillation
Arrhythmias, Cardiac
Stroke
agents, anti inflammatory
D-dimer
C-reactive protein

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents