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Colchicine in Atrial Fibrillation to Prevent Stroke

Information source: Population Health Research Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation; Stroke

Intervention: Colchicine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Population Health Research Institute

Official(s) and/or principal investigator(s):
Noel Chan, MD, Principal Investigator, Affiliation: Population Health Research Institute
John Eikelboom, MD, Principal Investigator, Affiliation: Population Health Research Institute

Overall contact:
Debi Sloane, Phone: 905-527-4322, Ext: 40408, Email: debi.sloane@phri.ca

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).

Clinical Details

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

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

Primary outcome:

Recruitment rates

Drop-out rates

Secondary outcome:

D-dimer

hs-CRP

Proportion of patients with a clinically significant adverse event

Drug adherence

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Debi Sloane, Phone: 905-527-4322, Ext: 40408, Email: debi.sloane@phri.ca

Hamilton General Hospital, Hamilton, Ontario L8L 2X2, Canada; Not yet recruiting
John Eikelboom, MD, Principal Investigator
Additional Information

Starting date: November 2014
Last updated: October 30, 2014

Page last updated: August 20, 2015

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