Colchicine in Atrial Fibrillation to Prevent Stroke

NCT ID: NCT02282098

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2020-11-17

Brief 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).

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

Atrial Fibrillation; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Active Colchicine

The intervention group will receive colchicine 0.6 mg twice daily orally for 3 months

Group Type: EXPERIMENTAL

Colchicine

Intervention Type: DRUG

Colchicine 0.6mg twice daily

Placebo Colchicine

The control group will receive colchicine placebo 0.6mg twice daily orally for 3 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Colchicine

Interventions

Colchicine

Colchicine 0.6mg twice daily

Intervention Type: DRUG

Placebo

Placebo Colchicine

Intervention Type: DRUG

Other Intervention Names

pms-Colchicine; Placebo Capsule

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Noel Chan

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noel Chan, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

John Eikelboom, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

NIF-14350

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NIF-14350

Identifier Type: -

Identifier Source: org_study_id