Colchicine in Atrial Fibrillation to Prevent Stroke "CIAFS-1"

Not yet recruiting

Phase 3 Results N/A

Trial Description

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).

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.

Conditions

Interventions

  • Placebo Drug
    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

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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

Sponsors