Colchicine in Atrial Fibrillation to Prevent Stroke

Stroke Clinical Trial

— CIAFS-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282098
• Other study ID #: NIF-14350
• Secondary ID: NIF-14350
• Status: Completed
• Phase: Phase 3
• Start date: November 2014
• Est. completion date: November 17, 2020

Study information

• Verified date: February 2021
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 17, 2020
• Est. primary completion date: November 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Drug:
• Colchicine
Colchicine 0.6mg twice daily
• Placebo
Placebo Colchicine

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rates	Number of eligible patients successfully randomized into study per year of study.	Randomization to Month 3
Primary	Drop-out rates	Proportion of participants withdrawing from study for any reason	Randomization to Month 3
Secondary	D-dimer	Mean D-dimer level at baseline and Month 3 for each arm	Randomization to Month 3
Secondary	hs-CRP	Mean level of hs-CRP at baseline and month 3 for each arm	Randomization to Month 3
Secondary	Proportion of patients with a clinically significant adverse event	Proportion of patients with side effects such as diarrhoea, myopathy requiring drug cessation	Randomization to Month 3
Secondary	Drug adherence	Proportion of missing pill to dispensed pill at 6 weeks and month 3	Randomization to Month 3