Colchicine in Atrial Fibrillation to Prevent Stroke

• Status: Completed
• Trial end date: 2020-11-17
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Colchicine

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.