Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
NCT Number: NCT02282098
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Hamilton, Ontario, L8L 2X2, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Colchicine 0.6mg twice daily
Other names: pms-Colchicine
Placebo Colchicine
Other names: Placebo Capsule
Time frame: Randomization to Month 3
Number of eligible patients successfully randomized into study per year of study.
Time frame: Randomization to Month 3
Proportion of participants withdrawing from study for any reason
Time frame: Randomization to Month 3
Mean D-dimer level at baseline and Month 3 for each arm
Time frame: Randomization to Month 3
Mean level of hs-CRP at baseline and month 3 for each arm
Time frame: Randomization to Month 3
Proportion of patients with side effects such as diarrhoea, myopathy requiring drug cessation
Time frame: Randomization to Month 3
Proportion of missing pill to dispensed pill at 6 weeks and month 3
Population Health Research Institute
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT04096781
Arrhythmia, Arrhythmias, Cardiac
Palo Alto, California, United States
View Trial DetailsNCT02428140
Arrhythmias, Cardiac, Atrial Fibrillation
Calgary, Alberta, Canada
View Trial DetailsNCT03761394
Arrhythmias, Cardiac, Atrial Fibrillation
Worcester, Massachusetts, United States
View Trial DetailsNCT05226416
Anemia, Arrhythmias, Cardiac
Moscow, Russia
View Trial Details