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).
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.
- Placebo Biological
Intervention Desc: Placebo Colchicine ARM 1: Kind: Experimental Label: Placebo Colchicine Description: The control group will receive colchicine placebo 0.6mg twice daily orally for 3 months.
- Colchicine Drug
Intervention Desc: Colchicine 0.6mg twice daily ARM 1: Kind: Experimental Label: Active Colchicine Description: The intervention group will receive colchicine 0.6 mg twice daily orally for 3 months
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Recruitment rates||Randomization to Month 3||No|
|Primary||Drop-out rates||Randomization to Month 3||No|
|Secondary||D-dimer||Randomization to Month 3||No|
|Secondary||hs-CRP||Randomization to Month 3||No|
|Secondary||Proportion of patients with a clinically significant adverse event||Randomization to Month 3||Yes|
|Secondary||Drug adherence||Randomization to Month 3||Yes|