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OpenTrials
Completed

NCT Number: NCT02282098

Colchicine in Atrial Fibrillation to Prevent Stroke

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Colchicine

Drug

Colchicine 0.6mg twice daily

Other names: pms-Colchicine

Placebo

Drug

Placebo Colchicine

Other names: Placebo Capsule

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study 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

Acronym: CIAFS-1

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Nov 4, 2014
Registry last updated
Feb 23, 2021

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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